Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
WO 2022/020377
PCT/US2021/042413
Systems and Methods for Obtaining and Monitoring Respiration, Cardiac
Function, and Other Health Data from Physical Input
CROSS REFERENCE TO RELATED APPLICATION(S)
[0001] This application claims the benefit of United States Provisional Patent
Application Serial No. 63/054,078, filed July 20, 2020. This application is
also a
Continuation-In-Part (CIP) of United States Utility Patent Application Serial
No.
17/228,249 filed April 12, 2021. The entire disclosure of all the above
documents is
herein incorporated by reference.
1
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present disclosure relates to physical sensors for the detection of
specific
health related conditions and systems and methods which can utilize that
output. In
particular, to physical sensors that monitor physical body changes in
respiration and
heart rate.
Description of the Related Art
[0003] Motion sensors and detectors are already in use in a variety of medical
areas.
For example, sensors located in a patient's bed or on a chair can be used to
sense
when a patient has gotten up, is attempting to stand, or has not moved for a
period of
time. These kinds of sensors can be used to detect that a patient is currently
at an
increased risk of falling, issue warnings before possible falls occur, detect
falls when
they occur, and alert against pressure ulcers in both hospitals and senior
care
facilities.
[0004] In the wake of the 2020 COVID-I9 virus pandemic, the human population
saw the global spread of a deadly disease leading to mass "social distancing
and the
use of respiratory masks in an attempt to halt its spread before vaccines
could be
made available. Social distancing was effectively a lighter form of quarantine
where
all individuals were intended simply to be kept at a distance from each other
so that
COVID- 19, which was believed to be spread from an infected individual to
others
primarily by airborne transmission, did not pass from an infected person (who
may
not have been aware they were infected) to one that was not. Masks or other
face
coverings, which ranged from homemade sewn fabric constructions to advanced
N95 particulate respirators, were also widely used to attempt to block
airborne
particulates ejected by one person from being inhaled by another.
2
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
[0005] The effectiveness of these measures is the subject of some debate and
because of the concern as to the various measures' effectiveness, a number of
other
tests were commonly used to attempt to determine if someone was sick, or more
importantly, contagious. For example, guidelines for interacting with others
during
the pandemic often required or suggested that an individual would need to have
a
normal (e.g. not elevated) body temperature to attend group events. For
example,
individuals such as children attending school or camp or adults entering
workplaces
often had to have their temperature taken, or to assert that they had taken it
and it
was normal, before entering and being allowed to interact with others.
[0006] The purpose of all this temperature taking was that elevated body
temperature is an indicator that the body is fighting infection. Thus, if one
has
elevated body temperature, the likelihood that they have some form of
infection is
increased. However, all this temperature taking was also still being done even
when
evidence began to show that temperature was likely a lagging indicator of
COVID-
19 infection as temperature usually is. This became relevant because the
individual
was believed to possibly be contagious long before they had elevated body
temperature.
[0007] As temperature taking during the COVID-19 pandemic illustrated, one
problem with many commonly used indications of sickness or injury is that they
are
lagging indicators. Often, the indicators are only interrogated when a person
"feels"
sick which may mean that the indicator is good at confirming illness, but not
good at
actually detecting it
[0008] The risk of another pandemic should not be trifled with. However, often
with
infectious disease the vinis or pathogen itself is not the danger, but the
human
body's response to the virus or pathogen is. The body's response often results
in
3
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
problems that are what actually causes permanent injury or death to the
individual.
For example, for respiratory ailments, respiratory distress including the
generation
of excess mucus in the respiratory system along with inflammation which can
lead
to coughing, nasal symptoms such as congestion (rhinitis) and runny nose
(rhinorrhea), headaches, and general weakness from the body's reduced capacity
to
handle air. In other diseases, the virus response can result in damage to
blood cells
which can in turn result in damage to blood vessels and heart tissue.
[0009] Outside of infection, degenerative illness, acute conditions, and
simple aging
can also cause changes to the operation of the body which can result in both
acute
dangers or long term degeneration in similar fashion to acute illness. For
example,
heart attacks result in the heart stopping which can result in death if not
detected
quickly. While heart attacks are an acute condition with immediate concern,
the
causes of heart attacks are often degenerative and take many months if not
years of
accumulation before the danger is realized. Similarly, degenerative illnesses
such as
Amyotrophic Lateral Sclerosis (ALS) can cause loss of motor control which can
result in trouble breathing due to inability to accurately control the lungs.
[0010] Detection of the alteration of the function of major body systems can
provide
an indication of potential disease, degeneration, or other condition in a way
that
allows for it to be corrected, before it becomes a problem. For example,
screenings
for various forms of cancer are common as they often allow for detection of
the
presence of a tumor before it has grown and spread in a way that is not easily
removed. Some of the most major body functions for life revolve around cardiac
function and respiration. However, disease in these areas if often
degenerative and
by the time a problem is identified, it often requires radical measures to
correct. For
example, it is fairly well recognized that clogged arteries causes the heart
to work
4
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
harder and can result in heart failure. However, it is often hard to detect
that the
heart is working harder than before because heart monitoring can be difficult
to
perform, invasive, and may require circumstances which are not everyday
occurrences.
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
SUMMARY OF THE INVENTION
[0011] The following is a summary of the invention in order to provide a basic
understanding of some aspects of the invention. This summary is not intended
to
identify key or critical elements of the invention or to delineate the scope
of the
invention. The sole purpose of this section is to present some concepts of the
invention in a simplified form as a prelude to the more detailed description
that is
presented later.
[0012] Because of these and other problems in the art, described herein are
sensors
which are generally included as part of a bed or chair or is attached to or
placed on
or under a mattress (but may be otherwise positioned to detect movement of a
human torso) for the physical detection of respiration and cardiac function
and
particularly alteration in respiration or cardiac function. The sensor may be
a
portion of a system which is designed to monitor respiration and cardiac
function
over time.
[0013] There is described herein, among other things, a sensor for detecting
cardiac
function or breathing of an animal, the sensor comprising: a support formed of
a
base and an outer wall; an accelerometer; and a spring, said spring at
equilibrium
suspending said accelerometer above said base; wherein when said spring allows
for
said accelerometer to be moved relative to said base.
[0014] In an embodiment of the sensor, the animal is a human.
[0015] In various embodiments of the sensor, the spring comprises elastic
bands, an
elastic flat surface material, flat spring steel, a leaf spring, a coil
spring, and/or a
disk spring.
[0016] In an embodiment of the sensor, the spring is attached to said outer
wall.
6
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
[0017] In an embodiment of the sensor, there is a void between said spring and
said
base which said accelerometer can move into.
[0018] There is also described herein a system for detecting cardiac function
or
breathing of an animal, the system comprising: a sensor comprising: a support
formed of a base and an outer wall; an accelerometer; and a spring, said
spring at
equilibrium suspending said accelerometer above said base; wherein when said
spring allows for said accelerometer to be moved relative to said base; and a
support
structure, mounting said sensor in a fashion that movement of a human torso
through
respiration or cardiac function causes said accelerometer to move relative to
said
base.
[0019] In an embodiment of the system, the support structure comprises a bed.
[0020] In an embodiment of the system, the support structure comprises a
chair.
[0021] In an embodiment of the system, the support structure comprises said
human
torso.
[0022] In an embodiment, the system further comprises a central computer for
receiving signals from said accelerometer via a network,
[0023] In an embodiment, the system further comprises a thermal sensor.
[0024] In an embodiment, the system further comprises a motion sensor.
[0025] In an embodiment, the system further comprises a depth sensor.
[0026] In an embodiment of the system, the central computer can compare said
received signals against other signals.
[0027] In an embodiment of the system, the other signals comprise prior
received
signals.
7
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1 depicts a general overview of an embodiment of a composite
system
for obtaining and monitoring respiration, heart rate, and other health data
from
physical input utilizing a physical sensor.
[0029] FIG. 2A shows a first embodiment of a sensor primarily for detecting
motion
of a patient's chest and which is suitable for inclusion within, on, or under
a mattress
or chair cushion or may be placed on a patient directly.
[0030] FIG. 2B shows a second embodiment of a sensor primarily for detecting
motion of a patient's chest and which is suitable for inclusion within, on, or
under a
mattress or chair cushion or may be placed on a patient directly.
[0031] FIG. 3 shows a third embodiment of a sensor for primarily detecting
motion
of a patient's chest and which is suitable for inclusion within, on or under a
mattress
or chair cushion or may be placed on a patient directly.
[0032] FIG. 4 shows a graph of output from a motion-detecting sensor showing
detection of a patient's heartbeat.
[0033] FIG. 5 shows two graphs of a motion-detecting sensor showing detection
of
the same patient as FIG. 4's respiration pattern.
[0034] FIG. 6 shows two graphs of a motion-detecting sensor showing detection
of
the same patient as FIG. 5's respiration pattern but using a different
detected
acceleration methodology.
[0035] FIG. 7 shows two graphs of a motion-detecting sensor showing detection
of
the respiration pattern of two different patients from the patient of FIG. 4,
but using
the methodology of FIG. 5.
[0036] FIG. 8 shows six graphs of a motion-detecting sensor detecting coughs
and
periods of fast breathing in six different patients.
8
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0037] Throughout this disclosure, the term "physical detection" or
"mechanical
detection" is used to broadly refer to technologies which detect changes in
the
physical world as opposed to chemical detection or biological detection.
Physical
detection in this disclosure will commonly utilize changes in movement
(including
starting, stopping, direction, acceleration, or velocity), or changes in
orientation.
Physical detection also includes changes to electrical or magnetic fields as
well as
alteration of structural processes and subatomic forces. In many respects,
physical
detection relates to detection of any change within electromechanical
parameters in
the operation of the human body as opposed to biological or chemical changes
(although such biological and chemical changes are recognized as often causing
the
changes in electromechanical parameters). Physical detection can be carried
out by
a wide variety of instruments, but devices such as motion detectors (including
cameras in all electromagnetic spectrums), accelerometers, magnetometers,
gyroscopes, and other types of well-known measurement devices are all capable
of
physical detection. Physical parameters including, but not limited to,
acceleration,
g-force, angular velocity or change in magnetic field can all be measured.
[0038] The term "computer" describes hardware which generally implements
functionality provided by digital computing technology, particularly computing
functionality associated with microprocessors. The term "computer" is not
intended
to be limited to any specific type of computing device, but it is intended to
be
inclusive of all computational devices including, but not limited to:
processing
devices, microprocessors, personal computers, desktop computers, laptop
computers, workstations, terminals, servers, clients, portable computers,
handheld
computers, cell phones, mobile phones, smart phones, tablet computers, server
9
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
farms, hardware appliances, minicomputers, mainframe computers, video game
consoles, handheld video game products, and wearable computing devices
including, but not limited to eyewear, wristwear, pendants, fabrics, and clip-
on
devices.
[0039] As used herein, a "computer" is necessarily an abstraction of the
functionality
provided by a single computer device outfitted with the hardware and
accessories
typical of computers in a particular role. By way of example and not
limitation, the
term "computer" in reference to a laptop computer would be understood by one
of
ordinary skill in the art to include the functionality provided by pointer-
based input
devices, such as a mouse or track pad, whereas the term "computer" used in
reference to an enterprise-class server would be understood by one of ordinary
skill
in the art to include the functionality provided by redundant systems, such as
RAID
drives and dual power supplies.
[0040] It is also well known to those of ordinary skill in the art that the
functionality
of a single computer may be distributed across a number of individual
machines.
This distribution may be functional, as where specific machines perform
specific
tasks; or, balanced, as where each machine is capable of perfonning most or
all
functions of any other machine and is assigned tasks based on its available
resources
at a point in time. Thus, the term "computer" as used herein, can refer to a
single,
standalone, self-contained device or to a plurality of machines working
together or
independently, including without limitation: a network server farm, "cloud"
computing system, software-as-a-service (SAAS), or other distributed or
collaborative computer networks.
[0041] Those of ordinary skill in the art also appreciate that some devices
which are
not conventionally thought of as "computers," nevertheless exhibit the
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
characteristics of a "computer" in certain contexts. Where such a device is
performing the functions of a "computer" as described herein, the term -
computer"
includes such devices to that extent. Devices of this type include, but are
not limited
to: network hardware, print servers, file servers, NAS and SAN, load
balancers, and
any other hardware capable of interacting with the systems and methods
described
herein in the matter of a conventional "computer."
[0042] Throughout this disclosure, the term "software" refers to code objects,
program logic, command structures, data structures and definitions, source
code,
executable and/or binary files, machine code, object code, compiled libraries,
implementations, algorithms, libraries, or any instruction or set of
instructions
capable of being executed by a computer processor, or capable of being
converted
into a form capable of being executed by a computer processor, including,
without
limitation, virtual processors, or by the use of run-time environments,
virtual
machines, and/or interpreters. Those of ordinary skill in the art recognize
that
software can be wired or embedded into hardware, including, without
limitation,
onto a microchip, and still be considered "software" within the meaning of
this
disclosure. For purposes of this disclosure, software includes, without
limitation:
instructions stored or storable in hard drives, RAM, ROM, flash memory BIOS,
CMOS, mother and daughter board circuitry, hardware controllers. USB
controllers
or hosts, peripheral devices and controllers, video cards, audio controllers,
network
cards, Bluetooth and other wireless communication devices, virtual memory,
storage devices and associated controllers, firmware, and device drivers. The
systems and methods described here are contemplated to use computers and
computer software typically stored in a computer- or machine-readable storage
medium or memory.
11
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
[0043] Throughout this disclosure, the term "network" generally refers to a
voice,
data, or other telecommunications network over which computers communicate
with
each other. The term "server" generally refers to a computer providing a
service
over a network, and a "client" generally refers to a computer accessing or
using a
service provided by a server over a network. Those having ordinary skill in
the art
will appreciate that the terms "server" and "client" may refer to hardware,
software,
and/or a combination of hardware and software, depending on context. Those
having ordinary skill in the art will further appreciate that the terms
"server" and
-client" may refer to endpoints of a network communication or network
connection,
including, but not necessarily limited to, a network socket connection. Those
having
ordinary skill in the art will further appreciate that a "server" may comprise
a
plurality of software and/or hardware servers delivering a service or set of
services.
Those having ordinary skill in the art will further appreciate that the term
"host"
may, in noun form, refer to an endpoint of a network communication or network
(e.g., "a remote host"), or may, in verb form, refer to a server providing a
service
over a network ("hosts a website"), or an access point for a service over a
network.
[0044] Throughout this disclosure, the term "transmitter" refers to equipment,
or a
set of equipment, having the hardware, circuitry, and/or software to generate
and
transmit electromagnetic waves carrying messages, signals, data, or other
information. A transmitter may also comprise the componentry to receive
electric
signals containing such messages, signals, data, or other information, and
convert
them to such electromagnetic waves. The term -receiver" refers to equipment,
or a
set of equipment, having the hardware, circuitry, and/or software to receive
such
transmitted electromagnetic waves and convert them into signals, usually
electrical,
from which the message, signal, data, or other information may be extracted.
The
12
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
term "transceiver" generally refers to a device or system that comprises both
a
transmitter and receiver, such as, but not necessarily limited to, a two-way
radio, or
wireless networking router or access point. For purposes of this disclosure,
all three
terms should be understood as interchangeable unless otherwise indicated; for
example, the term "transmitter" should be understood to imply the presence of
a
receiver, and the term "receiver" should be understood to imply the presence
of a
transmitter.
[0045] For purposes of this disclosure, there will also be significant
discussion of a
special type of computer referred to as a -mobile communication device" or
simply
"mobile device". A mobile communication device may be, but is not limited to,
a
smart phone, tablet PC, e-reader, satellite navigation system ("SatNav"),
fitness
device (e.g. a FitbitTM or JawboneTM) or any other type of mobile computer,
whether
of general or specific purpose functionality. Generally speaking, a mobile
communication device is network-enabled and communicating with a server system
providing services over a telecommunication or other infrastructure network. A
mobile communication device is essentially a mobile computer, but one which is
commonly not associated with any particular location, is also commonly carried
on a
user's person, and usually is in near-constant real-time communication with a
network.
[0046] The system may utilize a "positioning system" which is any form of
location
technology and will typically be a satellite positioning system such as GPS,
GLONASS, or similar technology, but may also include inertial and other
positioning systems, and wireless communication to enable detection of
location
such as beacon technology. Any wireless methodology for transferring the
location
data created by the positioning system to the other component parts of the
system to
13
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
which it is communicatively networked is contemplated. Thus, contemplated
wireless technologies include, but are not limited to, telemetry control,
radio
frequency communication, microwave communication, GPS and infrared short-
range communication.
[0047] The systems and methods described herein comprise sensors for physical
detection to detect patterns, and particularly changes to those patterns, in
human or
other animal respiration and/or cardiac function that are indicative of
declining or
altering health or indicative of upper or lower respiratory infection,
disease, allergy,
viral contamination or other issues of interest. As the physical detection can
be
sufficiently accurate to detect small changes imperceptible to a human user
(and
even a trained medical professional), the detection of potential illness can
take place
early in an infection or disease cycle and well in advance of the human
identifying
or suffering from symptoms. In an embodiment, the physical detection is
specifically the movement of the human's chest or torso as they breathe and/or
their
heart beats.
[0048] This disclosure will often discuss the need to detect changes in
respiration in
conjunction with the determination of whether or not a user is currently
infected
with a particular disease and, more specifically, is capable of infecting
others with
that disease. It should be recognized that such determination will generally
be
imperfect and the system cannot definitely state that any individual, at any
given
time, is or is not contagious to any other specific individual as too many
variables go
into that determination. Instead, the purpose of these systems and methods is
to
provide improved gatekeeping in such detection. Specifically, the systems and
methods discussed herein are designed to better deteimine when any individual
is
not contagious to most people compared to existing systems which typically
only
14
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
test individuals that already are at increased risk of being contagious to
determine if
they are.
[0049] Further, while the present disclosure will discuss the use of the
systems and
methods to detect transmissible infection, it should be recognized that any
system
which allows for more regular monitoring of human body function provides not
only
the ability to detect transmissible disease infection, but the ability to
detect alteration
of function which may be indicative of individual deterioration. Thus, while
the
systems and methods discussed herein provide for a number of benefits with
regards
to avoiding the need for broad lockdowns or gathering restrictions with
regards to
contagious diseases, they can also serve to provide increased data for health
monitoring individually and improved health outcomes for individuals and
populations.
[0050] Detection of potential disease or deterioration using the present
systems and
methods can occur in privacy or isolation for the patient and with the patient
remote
from a health care professional. Detection may also be perfoimed relatively
non-
invasively as the sensor is typically external to the body and may be placed
external
to clothing or other covers. As such, the data collection may be used in
public areas
to allow access to a gathering or other human activity where the presence of a
disease state in one individual could be dangerous to others present. This
type of
detection can, thus, provide advance notice of a disease state and potentially
provide
sufficient time for appropriate evaluation, isolation, monitoring and/or
medical
intervention to inhibit disease transmission or progression and/or possibly
before the
illness produces irreversible complications. In the case of possible
contamination to
other individuals, measures can also be taken to limit the spread of disease
and to
notify those with potential contact to an infected individual early to attempt
to halt
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
further spread. This can result in increased effectiveness (and acceptance) of
lockdowns, quarantines, and other isolating measures by better limiting them
only to
those who are an increased risk to others.
[0051] The systems and methods may be used for quick detection of infection or
changed state over a short time frame. Alternatively, they may be used for
monitoring of disease state over a long term. For example, long term data of
patients with degenerative illness may be obtained to monitor the disease
progression. This may be used, for example, to manage effects of the disease
even if
it is not medically possible to eliminate the disease or inhibit further
degeneration.
Further, the systems and methods discussed herein may also detect acute
changes in
long term illness which could indicate an immediate health concern requiring
an
immediate health response to prevent permanent injury or death.
[0052] In an embodiment, the systems and methods herein make use of the
mechanical movement of the chest and other externally visible body structures
to
detect the current state of the lungs and/or heart (which are not directly
visible). The
sensors (101A), (101B), and (101C) may be a part of a larger monitoring system
(100) for a patient (103), (105), and (107). The system may include other
sensors
(208), (209), or (210) where the readings are collated at a central computer
(201) or
similar system. The central computer may also have access to a variety of
source
information such as databases (203), (205), andlor (207). All communication
will
typically be through a network (301). The system (100) will typically be used
to
monitor those in a care facility such as a nursing home or hospital, but that
is by no
means required and the system (100) and the sensors (101) may be used at home
and
monitored by an individual user such as through a mobile communication device.
16
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
[0053] The sensors discussed herein may be tethered to the subject such as
being
placed against their chest, abdomen, or back and held in place with a strap or
similar
structure around their torso. They may also be simply positioned to rest on
the
chest, abdomen, or back utilizing gravity to hold them in place or may be held
in
place with a hand or similar restraint as shown with patient (103).
Alternatively, the
sensors may be placed on a bed or chair under a user (regardless of their
orientation
to the bed or chair), as shown with patient (105) and (107), or may be carried
by a
user or otherwise held in proximity to certain points of their body, or held
in place
with a strap or similar structure around their torso. While location on or
near the
chest to obtain information on heartrate and respiration is generally
preferred, it
should be recognized that the sensor can be placed elsewhere on the body. For
example, it may be placed on an arm to detect, for example, involuntary muscle
movement within the arm or over the lower torso to detect, for example,
intestinal
motion, diaphragm motion, or motion of a fetus during pregnancy.
[0054] It is generally preferred that the sensors (101) be untethered from the
patient
(that is not connected to the patient) and placed on or in a bed (patient
(105)) or
mattress (115) or on or in a chair (117) (patient (107)), regardless of their
orientation
to the bed or chair, or may be carried by a user or otherwise held in
proximity to
certain points of their body. When a sensor (101) is placed on or near the
body,
acceleration, g-force, angular velocity and magnetic field changes to the
chest area,
amongst other things can be measured. External changes to the human condition
(for example, that the chest rises and falls with inhalation and following
exhalation)
will commonly cause physical changes in the chest while the heart beats and
the
subject inhales and exhales.
17
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
[0055] FIGS_ 2A, 2B, and 3, provide for sensors specifically designed for the
purpose of measuring chest, abdomen, or other body part movement, particularly
of
a prone or sitting patient. These are useable as sensors (101) in FIG. I. In
FIGS.
2A, 2B, and 3 an accelerometer (401) is mounted to a support (404) via a
spring
(405), (407), or (409). In FIG. 2A, the spring (405) simply comprises elastic,
rubber, or similar bands or other supports having internal springiness. FIG.
2B is
similar, but the spring (409) comprises an elastic flat surface material such
as, but
not limited to, silicone or rubber, instead of bands. In FIG. 3, the spring
(407)
comprises a piece of flat spring steel, a leaf spring, a flat spring or
similar
component interconnecting the accelerometer (401) and support (404). It would
be
understood by one of ordinary skill in the art that alternative spring
structures
including without limitation, coil or disk springs, could be used in
alternative
embodiments.
[0056] The support (404) in all of FIGS. 2A, 2B, and 3 is generally in the
form of a
trough having a recessed base (431) and a surrounding outer wall (433). The
outer
wall (433) need not be of even height throughout the entire structure and need
not be
continuous across its entire length. Generally, the base (431) will, however,
be
recessed below the upper rim (435) of the outer wall (433). The spring (405),
(407),
or (409) will typically be attached to the upper rim (435) and extend
generally
linearly across the base (431) so as to space the accelerometer (401) above
the base
(431) ("floating") and create a void (413) between the base (431) and a plate
(415)
upon which the accelerometer (401) is mounted.
[0057] The spring (405), (407), or (409) will often be connected to the
support (404)
by having a portion of its structure sandwiched between the upper rim (435)
and the
lower surface (445) of a retaining block (403). The retaining block (403) will
often
18
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
include tightening connectors (441) such as, but not limited to, bolts or
screws
which allow it to be placed against the upper rim (435) and/or a portion of
the spring
(405), (407), or (409). These tightening connectors (441) may then be used to
compress the lower surface (445) into the upper rim (435) and portions of the
spring
(405), (407), or (409). The spring (407) may also or alternatively include
holes in its
structure allowing it to be trapped by the tightening connector (441) itself
or may be
attached via other methods such as, but not limited to, adhesives, welding, co-
molding, or co-foiniation.
[0058] The spring (405), (407), or (409) may be attached to the plate (415) in
similar
fashion to the support (404) by having the plate (415) comprise multiple parts
also
connected by tightening connectors, adhesives, or any other methods, means, or
structure. However, the plate (415) will often be of simplified construction.
In the
depicted embodiments of FIGS. 2A and 3, the plate (415) includes a plurality
of
cutouts (455) through which the spring (405) may be threaded in a woven
fashion so
as to generally entangle the plate (415) in the spring (405). This same shape
of plate
(415) is used in FIG. 3, however, in this the cutouts (455) are not used as
the plate is
attached to the spring (407) by adhesives or similar materials. In FIG. 2B,
the
cutouts (455) have been eliminated. In alternative embodiments, these
connection
methods may both be used on the same device.
[0059] The plate (415) will generally be attached to the spring (405), (407),
or (409)
in a manner that allows for the plate (415) and attached accelerometer (401)
to be
suspended above the void (413) in a position where the spring biasing force is
such
that the position is in equilibrium. Typically, the spring will be selected so
that the
mass of the plate (415) and accelerometer (401) is insufficient to result in
deformation of the spring (405), (407), or (409) of any significant amount
regardless
19
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
of orientation of the sensor (400), (500), or (600), but this is by no means
required_
The connection mechanism can be any which allows the plate (415) to be
compressed into the void (413). Typically, the plate (415) and accelerometer
(401)
will have a default position where the plate (415) is "floating" above the
void (413)
and can be compressed into the void (413) or extend out from the void (413)
depending on the force placed upon it.
[0060] It should be recognized that while the sensors (400), (500), and (600)
utilize
springs (405), (407), and (409) which are not generally located within the
void
(413), this is not absolutely required. In an alternative embodiment, a coiled
compression spring or similar compression spring such as, but not limited to a
leaf
spring or flat spring, can be attached to the base (431) and interconnected to
the
plate (415) as this also allows for the plate (415) to "float" above the void
(413)
even though the spring is within the void (413).
[0061] The void (413) allows for the plate (415) and accelerometer (401) to be
compressed from its default position above the void (413) into the void (413)
without movement of the support (404). By connecting the plate (415) to the
wall
(433) of the support (404), the compression force is distributed around the
edge of
the base (431). This can improve the likelihood of the plate (415) moving
within the
void (413) as opposed to a force on the plate (415) moving the entire sensor
(400),
(500), or (600). After compression, the plate (415) and accelerometer (401)
will
typically return to the default position and may actually extend further
briefly
depending on the amount to which it was compressed when any compression force
is removed. This construction of sensors (400), (500), and (600) allows for
the
accelerometer (401) to be moved relative to the support (404) quite easily
when
under a compression force while at the same time providing sufficient support
for
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
the accelerometer (401) that it can obtain a signal from its movement even if
it is a
relatively small perturbation. This structure allows for detection of
relatively small
movement of a nearby object while also accurately detecting its intensity.
[00621 In operation, the sensors (400), (500), and (600) will typically
operate as
follows. The sensor (400), (500), or (600) will be placed in a location that
will
generally end up being in contact with a patient's chest or in contact with
another
object which would transmit motion of the patient's chest to the accelerometer
(401). In alternative embodiments, other portions of the patient may
alternatively or
additionally be proximate the sensors (400), (500), and (600). For example,
the
sensor (400), (500), or (600) may be placed near a large artery or vein (such
as, but
not limited to, those in the neck, wrist, or upper legs) or may be placed in
an area
where body vibration is readily transmitted (such as, but not limited to,
against large
bones or against the back).
[0063] In a preferred embodiment, the sensors (400), (500), or (600) are
placed in,
on, or under a mattress or chair cushion so that when a user's mass is placed
against
them, the biasing of the spring (405), (407), or (409) is partially countered
by their
mass. This position allows for movement of the patient's body to perturb the
accelerometer (401) relative the support (404). The support (404) will
typically be
placed on the side opposing the patient so that the patient will be closer to
the
accelerometer (401) than the support (404). Thus, in a mattress arrangement,
the
support will typically be -down" and the accelerometer "up". This is by no
means
required, however.
[0064] In an alternative arrangement, the sensor (400), (500), or (600) may be
positioned so as to be directly attached to the patient. For example, the
sensor (400),
(500), or (600) may be placed on the patient's torso and attached to them via
a strap.
21
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
In such an arrangement, the support (404) will again typically be furthest
from the
patient so the accelerometer (401) would be closest to them and often in
contact with
their skin or clothes.
[0065] Regardless of the particular mounting, it should be apparent that small
changes in the pressure being applied to the sensor (400), (500), or (600)
from the
patient's chest moving will generally be readily detected as movement of the
accelerometer (401) relative to the support (404). Further, large scale
movements of
the user's body will often result in movement of both the accelerometer (401)
and
the support (404). This can allow for differentiation in signals.
Specifically, smaller
movements that will typically generate less force such as chest movement due
to the
user's breathing or heartrate will serve to perturb the accelerometer (401)
relative to
the support (404) by a relatively small amount while a large movement (such as
the
user's rolling over while on the sensor (400), (500), or (600) will serve to
move both
the accelerometer (401) and the support (404). This movement may be detectable
by the large size of the signal received by the accelerometer (401) which
would
indicate that the accelerometer (401) moved further than expected due to
movement
of the support (404). The accelerometer (401) may not also return to the same
position it started showing a greater movement in one direction. These can
indicate
that the movement is caused by a gross motor movement as opposed to a desired
perturbation such as inhalation or heartbeat.
[0066] Once positioned, the sensor (400), (500), or (600) can serve to provide
indications of accelerometer (401) motion to an analysis system. This will
typically
be a computer and may receive the signals from the sensor (400), (500), or
(600) via
a cable (491) or via a wireless transmission if the accelerometer (401) is so
equipped. These signals are typically indicative of the movement of a
patient's
22
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
chest or other body structure and can be used to monitor breathing, heartbeat,
or
other factors of the patient.
[0067] The combination of waveforms from these sensors can be processed by
algorithms to identif,' heartbeats and estimate respiration or heart operation
features
or patterns. Certain combinations of features (for example, specific waveforms
of
inhalation, timing of heartbeat, or shape of waveform caused by heartbeat or
inhalation) are then correlated to early signs of potential infection,
respiratory issues
or other illness. This correlation can be carried out at a macro scale level
where
waveforms from one specific user are compared to waveforms gathered from a
large
group of other users both with and without respiratory conditions of interest.
Alternatively, or additionally, changes in waveforms patterns over time for
each
person individually (comparing current waveforms from that individual against
prior
waveforms from that individual) may also be correlated to signs of potential
infection, respiratory issues, or other illness.
[0068] Monitoring of changes in the patterns over time typically allows for
more
accurate identification of potential illness (less false alarms), earlier in
time, allows
for more conditions to be detected and also allows for the system to adjust on
a
personal level for each individual. Adjusting for each individual is generally
preferred as each person's "regular" condition is different. That is, each
person's
physiology typically results in them generating different waveforms. However,
both
the features indicating illness and the deteriorating health patterns can be
predetermined by experts in the field (such as pulmonologists or
cardiologists) or
learned by the system over time (such as through the use of a neural net or
other
"artificial intelligence" technology) for each person.
23
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
[0069] This may be accomplished, for example, by establishing a baseline set
of
features and parameters and monitoring for changes. As an example, coughing,
shortness of breath (gasping breaths), number of respirations per minute,
depth of
breath, completeness of breath, or timing or shape of heartbeat could all be
estimated by the waveforms of the aforementioned sensory equipment and the
values or changes of values over time correlated to particular irregularities
due to
illness. As another example, signs of cardiovascular compensation for
incomplete
blood oxygenation can be identified by evaluating simultaneously changes in
heart
and respiratory rates.
[0070] FIGS. 4 through 8 provide for various graphs of waveforms which are
indicative of physical characteristics of particular patients. FIG. 4 provides
for an
indication of the detection of heart rate via linear acceleration as detected
by a
sensor such as sensor (400), (500), or (600). As should be apparent,
individual beats
are easily detected and the heartrate can be readily determined by simply
reviewing
the beats over time.
[0071] FIGS. 5 through 7 provide for various different graphs showing patterns
of
respiration. These are generated via various different forms of sensing of
acceleration from sensors such as sensors (400), (500), or (600). In FIG. 5,
acceleration with g is used. FIG. 6 uses rotational acceleration on the same
patient
as FIG. 5. FIG. 7 utilizes acceleration with g for two different patients than
FIG. 5.
As should be apparent, the graphs (which may be referred to as
"Respirographs") in
FIG. 7 show differences from each other with the top graph showing longer
troughs
while the lower graph shows longer more flat-topped peaks. This is compared to
FIG. 5 which shows a more regular sinusoidal type wave. While the various
graphs
are from different individuals, they clearly show different ways of breathing.
Some
24
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
of the differences may be pathological (for example, subject B suffers from
asthma)
or may simply comprise differences from individuals. The software is able to
determine differences both within an individual's pattern over time and
between
individuals with or without known conditions (for example if they do or do not
have
asthma) and can alert accordingly for detected changes or the potential
presence of
chronic conditions.
[0072] FIG. 8 shows that particular patterns in breathing can be detected
across
patients. Specifically, the 6 graphs of FIG. 8 show six different patients
using
sensors such as sensors (400), (500), or (600). The patients each cough and
have
that followed by a period of fast shallow breathing. These elements are each
readily
detectible on all six graphs. Further, the cough is also clearly
differentiable from the
shallow breathing. As would be expected, fast shallow breathing results in
dramatically increased acceleration while the cough produces a large
acceleration
from the force produced by the muscles of the chest to cough. These structures
and
corresponding actions are easily identified, even though each patient has
different
specific graphs as can be seen.
[0073] While the above FIGS. show that individual differences in breathing can
be
readily detected (FIGS 5 through 7) it also shows that common actions such as
coughing or changed breathing (FIG. 8) can also be readily detected. This dual
detection can be used to monitor an individual and/or population to detect
both acute
concerns as well as overall changes.
[0074] FIG. 1 illustrates an embodiment of a system for collating respiration
information from a number of users. Human users (103), (105), and (107) would
be
provided with sensors (400), (500), or (600) in various locations. In one
example, a
user (103) could have a sensor (101A) placed on them while lying as
illustrated by
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
user (103). The sensor (101A) could sense strength of heartbeat and pace of
respiration or other factors of the user to determine if the location is as
desired for
measurement. Should the measurement window be sufficient, other aspects of
breathing such as a cough, sneeze, or hiccup could be detected. It should be
recognized that a patient that has respiratory distress is far more likely to
cough or
sneeze during the measurement window. Further, patients that are having
difficulty
breathing are more likely to have their breathing become quicker.
[0075] Alternatively, the sensor (101B) may be placed on, under or within the
mattress (115) of a patient (105) in a nursing home who is unable to leave bed
without assistance. This device (101B) may operate according to a set time
schedule
or even constantly instead of when activated by the user or under specific
circumstances. A still further sensor (101C) could be placed in a chair (117)
in the
room of a patient (107) in a hospital isolation ward and simply activated by
pressure
when they sat down. In the depicted embodiment sensor (10IC) is actually two
linked devices as shown to provide different monitoring locations.
[0076]The user (103) may be instructed to breathe normally or to carry out a
specific series of breathing exercises such as specifically taking the deepest
breaths
possible or to breathe and hold their breath for a period of time. They could
also be
asked specifically to cough or to move in a particular way. The users (105)
and
(107) may be similarly instructed or may be passively monitored. Regardless,
the
sensors (101A), (101B), or (101C) would then record the data related to the
chest
and/or abdominal movement of the user (103), (105), or (107) during these
actions.
[0077] This data could then be transferred using a transmitter or similar
device to a
server (201) via the Internet (301) or another network. The data may be
packaged
with other data from the sensors (101) such as time or location information. A
user
26
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
(103) or a caregiver for a user (105) or (107) may also be specifically
requested to
enter additional information in the transmission such as a current health
state, if they
had difficulty performing any of the breathing exercises, or if they believe
they may
have been exposed to a certain illness since the last time they utilized the
sensor.
This user-supplied data can also be combined with the collected motion data.
[0078] Data from the sensors (101) may also be combined with data from other
monitoring systems such as, but not limited to, systems in the room for
monitoring
the patient for other conditions. For example, thermal sensors (208) may be
used to
make sure that the data obtained by the mobile device (101) appears to be from
a
human patient in the room and not a different signal. This is similar to how
such
thermal signals may be used to detect a human user for fall detection as
discussed in
United States Patent 10,453,202, the entire disclosure of which is herein
incorporated by reference. Thermal sensors (208) may also be used to determine
if a
patient is feverish in an embodiment such as is described in United States
Patent
Application Publications 2008/0154138, 2007/0153871, and 2016/0150976, the
entire disclosure of all of which is herein incorporated by reference.
[0079] Similarly, monitoring systems such as motion sensor (209) and depth
sensor
(210) which may be in the room for fall detection such as is described in
United
States Patents 8,890,937; 9,408,561; 9,597,016; 10,080,513; 10,188,295; and
10,206,630, the entire disclosures of all of which are herein incorporated by
reference, may also supply data on the patient which may be combined with the
data
from the sensor (101). Any and all data may be sent to the server (201)
encrypted
and/or anonymized to protect privacy of the user (103), (105) or (107).
[0080] The central server (201) may receive the data from a plurality of
sensors
(101A), (101B), and (101C) and may collate and analyze the data from this
plurality
27
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
for patterns and correlations_ If certain patterns are detected, this may be
combined
with general information available from databases (203), (205), and/or (207)
to
which the server (201) has access. For example, if the server (201) received
information from sensors (101) in location A which appeared anomalous, the
server
(201) may look to public health databases (203) or news databases (207) to
determine if there may be an outbreak of a particular illness (such as, but
not limited
to, flu or SARS) reported in location A.
[0081] The server (201) may also obtain specific health related information
related
to the patterns. For example, information collected by other monitors (such
as, for
example an electrocardiogram, blood oxygenation reading, diagnosis, and
eventual
outcome) could be obtained from (typically anonymized) medical records (205)
of a
patient that was hospitalized for a certain condition after showing similar
pattern
changes in breathing.
[0082] If certain elements of the data received from the sensor (101) of any
user are
cleteimined to potentially be indicative of a certain illness or condition,
the system
(100) may notify the user of the mobile device (101) that such has been found
and
suggest they consult a health professional. The data may additionally or
alternatively be passed to a health professional or caregiver that the user
may have
already indicated as authorized to receive their information. This person
could then
evaluate the data and conclusion and potentially contact the user directly, or
institute
care or monitoring, if they deemed such actions relevant.
[0083] While the invention has been disclosed in conjunction with a
description of
certain embodiments, including those that are currently believed to be useful
embodiments, the detailed description is intended to be illustrative and
should not be
understood to limit the scope of the present disclosure. As would be
understood by
28
CA 03175250 2022- 10- 11
WO 2022/020377
PCT/US2021/042413
one of ordinary skill in the art, embodiments other than those described in
detail
herein are encompassed by the present invention. Modifications and variations
of
the described embodiments may be made without departing from the spirit and
scope of the invention.
[0084] It will further be understood that any of the ranges, values,
properties, or
characteristics given for any single component of the present disclosure can
be used
interchangeably with any ranges, values, properties, or characteristics given
for any
of the other components of the disclosure, where compatible, to form an
embodiment having defined values for each of the components, as given herein
throughout. Further, ranges provided for a genus or a category can also be
applied
to species within the genus or members of the category unless otherwise noted.
[0085] The qualifier "generally," and similar qualifiers as used in the
present case,
would be understood by one of ordinary skill in the art to accommodate
recognizable attempts to conform a device to the qualified term, which may
nevertheless fall short of doing so. This is because terms such as "spherical"
are
purely geometric constructs and no real-world component or relationship is
truly
"spherical" in the geometric sense. Variations from geometric and mathematical
descriptions are unavoidable due to, among other things, manufacturing
tolerances
resulting in shape variations, defects and imperfections, non-uniform thermal
expansion, and natural wear. Moreover, there exists for every object a level
of
magnification at which geometric and mathematical descriptors fail due to the
nature
of matter. One of ordinary skill would thus understand the term -generally"
and
relationships contemplated herein regardless of the inclusion of such
qualifiers to
include a range of variations from the literal geometric meaning of the term
in view
of these and other considerations.
29
CA 03175250 2022- 10- 11