U.S. patent application number 15/358974 was filed with the patent office on 2017-03-16 for method and device for patient monitoring using dynamic multi-function device.
The applicant listed for this patent is Cardiac Technologies International, Inc.. Invention is credited to Ryan M. Buck, Frederick M. Hijazi.
Application Number | 20170071469 15/358974 |
Document ID | / |
Family ID | 54067596 |
Filed Date | 2017-03-16 |
United States Patent
Application |
20170071469 |
Kind Code |
A1 |
Hijazi; Frederick M. ; et
al. |
March 16, 2017 |
Method and Device for Patient Monitoring Using Dynamic
Multi-Function Device
Abstract
The present invention is directed to an improved method, system
and product to provide wireless ECG patient monitoring. Although
embodiments make specific reference to monitoring electrocardiogram
signal with an adherent patch, the system methods, and device
herein may be applicable to any application in which physiological
monitoring is used. The present invention also presents a reliable
means for docking the interface while minimizing signal
interference and user error. In addition, a novel means for
transmitting and receiving a patient's ECG measurements is
introduced which includes the use of an epidermal communication
network (ECN) and an ECG enabled module for ECN communications and
interface. Although embodiments make specific reference to the use
of the ECN for ECG measurements, the system methods, and protocol
herein may be applicable to any wearable device and/or other smart
device which is ECN enabled.
Inventors: |
Hijazi; Frederick M.;
(Boulder, CO) ; Buck; Ryan M.; (San Francisco,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardiac Technologies International, Inc. |
Santa Fe |
NM |
US |
|
|
Family ID: |
54067596 |
Appl. No.: |
15/358974 |
Filed: |
November 22, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14660515 |
Mar 17, 2015 |
9498129 |
|
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15358974 |
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61954501 |
Mar 17, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2560/0204 20130101;
A61B 5/04085 20130101; G06F 3/04855 20130101; A61B 5/04087
20130101; A61B 5/0006 20130101; A61B 5/0432 20130101; A61B 5/6804
20130101; A61B 5/6833 20130101; A61B 5/0028 20130101; A61B 5/0402
20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/0432 20060101 A61B005/0432; G06F 3/0485 20060101
G06F003/0485; A61B 5/0408 20060101 A61B005/0408 |
Claims
1. A system comprising: a memory; a transceiver, the transceiver
configured to: receive data signals from a communication device,
said communication device comprising a leadless monitoring device;
a processor, the processor configured to: determine if the
communication device is enabled to operate on an epidermal
communication network (ECN); treat the data signals received for
communication over the ECN; and process the data signals using an
analog-front-end located in the system; and a docking component for
interfacing the communication device to operate on the ECN, wherein
interfacing the communication device on the system includes
placement of the communication device on the system via direct
attachment and/or via at least one of a DART, USB, and SPI; and
wherein the data signals received travel on the ECN and take the
form of a parasitic coupling, wherein a path of the parasitic
coupling is between a signal-out and a signal-in and occurs through
the skin of a user, and said parasitic coupling is stronger than
that of a coupling that occurs through the air between a ground of
a transit module and the ground of a receive module.
2. The system of claim 1, wherein the wherein the leadless
monitoring device includes an ECG measurement system for measuring
the bio-potential electrical activity of the heart of a user,
wherein the leadless monitoring device includes a plurality of
contact electrodes and inductive coil for inductive charging.
3. The system of claim 2, wherein the plurality of contact
electrodes are assigned to a clock role by a System Management Bus
Protocol, and where charging of the communication device occurs
after a hand-shake authentication with a host system.
4. The system of claim 2, wherein the leadless monitoring device
further includes an LCD display for data retrieval and health
monitoring, and wherein the leadless monitoring device includes a
scroll wheel, the scroll wheel is used to secure access to user
information and as a mechanism for scrolling through menu
options.
5. The system of claim 2, wherein the leadless monitoring device
can be affixed to the user via one or more of an adhesive onto a
skin of the user, a garment, the system, and other electronic
component.
6. The system of claim 2, wherein the system allows communication
between the communication device and a wireless communication
device for recording an electrocardiogram of the user.
7. The system of claim 1, wherein the epidermal communication
network includes transmission and reception of data signals across
the epidermis of a body, wherein the epidermal communication
network provides a medium for transferring the user information
from the communication device to one or more secondary devices,
wherein the one or more secondary devices include one or more of
an: epidermal communication network enabled wearable device, a
wired external device with an epidermal communication network
enabled interface, a wireless external device with an epidermal
communication network enabled interface, a smart module docketed on
an epidermal communication network enabled interface, and/or an
ingestible sensor, wherein the patient information includes vital
records, demographic information, personal information,
credentials, and/or bank information, wherein the personal
information is encrypted and necessitates the use of a fingerprint
scanner to access.
8. The system of claim 1, wherein the received data signals are
processed by an analog front-end.
9. A method comprising: receiving, by a transceiver, data signals
from a communication device, said communication device comprising a
leadless monitoring device; determining, by a processor, if the
communication device is enabled to operate on an epidermal
communication network (ECN); treating, by the processor, the data
signals received for communication over the ECN; and processing, by
the processor, the information from the data signals using an
analog-front-end located in the system; employing a docking
component for interfacing the communication device to operate on
the ECN, wherein interfacing the communication device on the system
includes placement of the communication device on the system via
direct attachment and/or via at least one of a UART, USB, and SPI;
and receiving the data signals that travel on the ECN in the form
of a parasitic coupling, wherein a path of the parasitic coupling
is between a signal-out and a signal-in and occurs through the skin
of a user, said parasitic coupling being stronger than that of a
coupling that occurs through the air between a ground of a transit
module and the ground of a receive module.
10. The method of claim 9, further comprising a docking component
for interfacing the communication device to operate on the ECN,
wherein docking the communication device on the system includes
placement of the communication device on the system via direct
attachment and/or via at least one of a UART, USB, and SPI, and
wherein the system operates as an interface to enable communication
with the communication device.
11. The method of claim 9, wherein the leadless monitoring device
includes an ECG measurement system for measuring the bio-potential
electrical activity of the heart of a user, wherein the leadless
monitoring device includes a plurality of contact electrodes and
inductive coil for inductive charging.
12. The method of claim 9, wherein the leadless monitoring device
further includes an LCD display for data retrieval and health
monitoring, and wherein the leadless monitoring device includes a
scroll wheel, the scroll wheel is used to secure access to user
information and as a mechanism for scrolling through menu
options.
13. The method of claim 9, wherein the system allows communication
between the communication device and a wireless communication
device for recording an electrocardiogram of the user.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/6660,515, filed on Mar. 17, 2015 (now U.S.
Pat. No. 9,498,129, issued Nov. 22, 2016), and claims priority from
U.S. Provisional Patent Application Ser. No. 61/954,501, filed Mar.
17, 2014. The entire disclosure of the prior applications are
considered to be part of the disclosure of the accompanying
application and are hereby incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention is directed to a method, system and
device for simple wireless electrocardiogram monitoring. In
particular, the invention is directed to the use of a wireless ECG
with reliable functionality, data-log information access,
intrinsically safe charging, and capacity to communicate via an
epidermal communication network. Communication over the epidermal
communication network can occur in conjunction with an epidermal
communication network enabled module.
BACKGROUND
[0003] Heart disease is the leading cause of death in the United
States. A heart attack, also known as an acute myocardial
infarction (AMI), typically results from a blood clot or "thrombus"
that obstructs blood flow in one or more coronary arteries. AMI is
a common and life-threatening complication of coronary artery
disease. Coronary ischemia is caused by an insufficiency of oxygen
to the heart muscle. Ischemia is typically provoked by physical
activity or other causes of increased heart rate when one or more
of the coronary arteries is narrowed by atherosclerosis. AMI, which
is typically the result of a completely blocked coronary artery, is
the most extreme form of ischemia. Patients will often (but not
always) become aware of chest discomfort, known as "angina", when
the heart muscle is experiencing ischemia. Those with coronary
atherosclerosis are at higher risk for AMI if the plaque becomes
further obstructed by thrombus.
[0004] Detection of AMI often involves analyzing changes in a
person's ST segment voltage. A common scheme for computing changes
in the ST segment involves determining a quantity known as ST
deviation for each beat. ST deviation is the value of the
electrocardiogram at a point or points during the ST segment
relative to the value of the electrocardiogram at some point or
points during the PQ segment. Whether or not a particular ST
deviation is indicative of AMI depends on a comparison of that ST
deviation with a threshold.
[0005] Acute myocardial infarction and ischemia may be detected
from a patient's electrocardiogram (ECG). An ECG is a highly useful
diagnostic aid for clinicians, for the study of heart rate and
rhythm. An electrocardiogram is defined to be the heart's
electrical signal as sensed through skin surface electrodes that
are placed in a position to indicate the heart's electrical
activity. The ECG indicates the propagation of low amplitude
electrical signals, commonly referred to as the cardiac impulse,
across the myocardium giving information about depolarization and
repolarization characteristics of the heart.
[0006] An ECG typically receives signals from a plurality of
electrodes (3, 5, and 12 are common numbers). Historically, the
12-lead surface electrocardiograph has been the most commonly used.
A surface ECG refers to placement of electrodes on the surface, or
skin, of the patient as opposed to directly to cardiac tissue which
obviously requires an invasive procedure. This method attaches
about 10 wired electrodes to a patient's body in order to measure
the bio-potential activity of the patient and uses the electrodes
to transfer the information into the electrocardiogram. The
measurement is possible because electric activity surfaces from the
cardiac muscle to the skin and dissipates throughout the conductive
skin layer. Since the skin has electric impedances, the
conductivity of the electric current varies depending on the
direction of the measurement and the separation distance of between
the measurement electrodes. The ECG monitors voltage signals
appearing between various pairs of the electrodes and performs a
vector analysis of the resultant signal pairs to prepare various
two-dimensional voltage-time graphs indicative of internal cardiac
activity.
[0007] ECG measurements have been conducted for over 200 years, and
a standard configuration of the measurement vector leads have been
adopted by the medical and engineering communities. This standard
of leads formation and configuration require substantial separation
of points of measurements on the surface of the skin, which
necessitates connection of two remote points by lead wires into an
instrumentation amplifier. This large separation between electrode
contact points maximizes the surface area of the skin between the
measurement electrode points and therefore maximizes the impedance,
and measured voltage potential across the contact electrodes.
[0008] The use of the conventional ECG requires large separation
between electrodes in order maximize impedance and measure the
voltage potential across the contact electrodes. The required
separation, leads to large wired footprints on the patient.
[0009] If the distance d is too small the bipolar ECG signals will
be buried in the noise. If d is increased the signals will increase
and in the most extreme variant the measuring electrodes will be
positioned as in the EASI system, stretching over the whole torso.
However, in the EASI system four unipolar measurements are used to
synthesize a standard 12-lead system. In the process of
synthesizing ECG from non-standard electrode placement (such as the
EASI system and the system disclosed herein) parameters are used to
transform the non uniform ECG to standard ECG leads. However, the
variance in body impedance between different people is an evident
source of error.
[0010] Further, the use of a wired monitoring system makes taking a
patient's ECG very uncomfortable. Even further, wired devices make
patient monitoring very cumbersome for the practitioners and
increases the probability of infection due to the exposure of
bodily fluid by the wires. To overcome these shortcomings
associated with wired monitoring, the use of wireless monitoring
devices is being investigated. Wireless monitoring devices will
provide increased comfort for a patient, decreased lead-off alarms
due to tugged wires, reduced error in lead connection and reduced
substantial motion artifacts and RF interference.
[0011] Further, providing an epidermal communication network (ECN)
where these and other wireless devices can communicate without the
need for wired or wireless connectivity can further enhance a
user's experience, reduce power consumption and increase data
throughput. The ECN is a novel communication means for transmitting
and receiving information across the human body. By using the human
body as a communication network, seamless integration of smaller,
less obstructive, and more naturally integrated wireless sensors
across the entire body can be possible.
[0012] In U.S. Pat. App. No. 2012/0165633 to Mohammad Khair,
partial wireless monitoring was introduced. The ECG measurement
system uses wired electrodes only for calibration purposes. In this
method, the calibration is started from the ECG receiver unit which
sends selection signals and synchronization pulses via its radio
module to the radio module of each ECG sensing unit. As a
consequence, preselected passive electrodes are connected to each
ECG sensing unit, in predetermined sequences, such that the
measuring module of each ECG sensing unit generates signals.
Following an A/D-conversion and data processing in the data
processing unit, local bipolar data for each ECG sensing unit and
calculated standard ECG data are stored digitally in a buffer
memory in the data processing unit. This digitally stored data
representing one and the same heart beat, are then compared in
order to determine the parameters of a transfer function by which
the standard ECG leads may be synthesized from the local bipolar
ECG data. Once these parameters have been determined, the
calibration phase can be terminated and the passive electrodes can
be detached from the body of the patient and the multi cable
connection can be disconnected from the ECG sensing units.
[0013] However, this solution is not a complete wireless solution
and the use of wired electrodes still makes it very cumbersome to
work with. With the current advancements in technology and
electronics (i.e. the use of instrumentation amplifiers), the
separation required for ECG measurements is decreasing, thus making
it easier to find a reliable wireless monitoring device.
[0014] In U.S. Pat. No. 5,811,897 to Spaude et al, a device for
body-bound data transmission is introduced and incorporated herein
in its entirety. The transmission of the data between two terminals
in which a portion of the body of a user completes the data
transmission circuit is described. A first terminal is worn by a
body of a user, and an interface is provided for coupling the data
signals into the body and/or for coupling them out of the body. A
second terminal with a touch-sensitive interface by way of which,
in the case of a contact by the body wearing the first terminal,
couples data signals coupled into the body out of the body and/or
couples data signals into the body.
[0015] However, this solution is not the most efficient. It
requires the use of two or more pairs of electrodes on each part of
the body terminals. Further, the solution presented by Spaude
requires the transmission of signals through the body as high
frequencies are referenced. A need for a wireless single electrode
solution communicating at low frequencies with low power
consumption is needed. Therefore, it is the object of the current
embodiment to present a wireless monitoring device with the
capability to communicate over an epidermal communication
network.
SUMMARY OF THE INVENTION
[0016] The present invention is directed to an improved method,
system and product to provide wireless ECG patient monitoring.
Although embodiments make specific reference to monitoring
electrocardiogram signals with an adherent patch, the system,
methods, and device herein may be applicable to any application in
which physiological monitoring is used. Unlike prior art methods
and devices which require a wired solution to enable patient
monitoring, this solution presents a safe, intuitive means for
making ECG measurements without the use of wires. It is therefore
an object of the present invention to provide a leadless wireless,
ECG measurement system and method for measuring of bio-potential
electrical activity, while having improved design and performance
as compared to prior art systems. It is another object of the
present invention to provide a leadless, wireless ECG measurement
system and method for measuring of bio-potential electrical
activity of the heart which uses measurements across smaller
separation distances between the electrode contact points as
compared to prior art systems. It is still another object of the
present invention to provide an ECG measurement system and method
which is much more compact in its form and coverage area as
compared to prior art systems. It is still yet another object of
the present invention to provide an ECG measurement system and
method which produces a higher degree of comfort for the patient by
eliminating lead wires extending to distal electrodes. It is
another object of the present invention to present an ECG
measurement system and method that is easier to use and provides
greater flexibility in placement for the user, does not decrease
measurement accuracy and has a smaller footprint than other
conventional ECG devices. It is yet another object of the present
invention to use an Epidermal Communication Network (ECN) to
transmit ECG measurements a remote center. It is another object of
the present invention to provide an epidermal communication network
that permits synchronization between sensors and/or communication
between individual sensors, network of sensors, ECN enabled
sensors, ECN modules, and ECN enabled interfaces, etc. In still
another embodiment of the present invention, the single electrode
wearable sensors communicate on the epidermal layer of the body at
very low frequencies.
[0017] These and other objects, features and advantages of the
invention are provided by a leadless wireless ECG measurement
system for measuring of bio-potential electrical activity of the
heart in a patient's body which includes at least one multi-contact
bio-potential electrode assembly adapted for attachment (or close
orientation to) to the patient's body. In one embodiment, the
electrode assembly is formed of an electronic patch layer and a
disposable electrode layer. The disposable electrode layer can have
a plurality of contact points for engagement with the surface of
the patient's body and is configured to measure ECG signals in
response to electrical activity in the heart. Furthermore, the
present invention also presents a reliable means for docking the
monitoring device to an interface while minimizing signal
interference and user error.
[0018] Certain embodiments of the present invention also provide a
means for charging the device in an intrinsically safe manner.
Certain embodiments employ strong magnetic contacts to retain
portions in proper placement, e.g. between the mediums to enable a
secure fit.
[0019] Still other embodiments of the present invention provide a
mechanism for data-log access information. With the use of smart
detection hardware, various embodiments can employ a device that
can incorporate intelligent switching, which may be dynamically
re-configured to detect various user inputs.
[0020] Still yet other embodiments of the present invention provide
a method for synchronizing sensors in order to obtain reliable
data, with synchronization providing a dependable way for obtaining
bi-potential measurements.
[0021] The electronic component in any of the devices described
herein may include a processor having a memory with computer
readable instructions to record signals from the first and second
electrodes while the electronic device is attached to the patient.
In a preferred embodiment, the processor may be configured to only
convert signals from the electrodes to digital signals, filter
those signals and then store the signals in memory.
[0022] Various embodiments are directed to the provision of a
device and method for the monitoring of a patient, preferably in a
manner such that detection, signaling, conveyance of signals and
display of relevant information is accomplished with unprecedented
speed, economically and with outside observers unaware that such a
system is being employed. In many embodiments, the contacts may
vary in size, shape and location. The particular dimensions,
thickness, size, area surface, texture, flexibility, adhesive
characteristics, and composition for the particular device can be
adjusted as one of the skill in the art will appreciate.
[0023] In various embodiments of the present invention, the
monitoring device is an adherent device that is adhered to a skin
of the patient. In others, however, due to, for example,
sensitivity to adhesives, especially over a prolonged period of
time, other skin association mechanisms are employed to obtain
desired contact. Thus, apparel can be fitted so that there are
apertures that permit skin contact with electrodes so as to achieve
solid contact needed for signal communications. While the
discussion herein is primarily directed to adhesive patches, it
will be understood that other electrode contact means are possible
to employ and are well within the scope of the present invention.
In many embodiments of the present invention, an electrocardiogram
signal is measured when the adherent patch is adhered to the
patient or docketed to an interface. An adhesive patch with an
adhesive to adhere the support to the patient is preferably used.
The adhesive patch may comprise a breathable tape with adhesive to
adhere the support to the patient. The adhesive patch may further
encompass a piece of soft material with an adhesive that can cover
a part of the body as described in U.S. Pat. No. 8,460,189 entitled
"Adherent Cardiac Monitor with Advanced Sensing Capabilities"
issued to Libbus et al., on Jun. 11, 2013, which is further
incorporated by reference herein.
[0024] The adhesive patch can aid in providing a better fit and
conductivity in placement of the monitoring device for better
adherence and increased signal quality in transmission over an
epidermal communication network. The adhesive device can further
include micro-spikes which aid in the coupling and signal transfer
between the monitoring device and/or another wearable device, a
wired device, a wireless device and other devices of the like. The
microspikes can include an adhesive bandage, patch, or other
similar material on the monitoring device or on as a separate
mechanism that includes miniature speared objects that can
minimally penetrate the skin to a more conductive layer for better
user coupling and signal transmission. Alternatively or in
addition, a body lotion or other viscous substance can be applied
on the epidermis of the user to increase the conductivity for
better signal transmission.
[0025] Another aspect of the present invention is directed to the
use of an interface between a disposable multi-electrode patch and
the enclosure. In one embodiment of the present invention,
conductive magnetic contacts may be used for each of the signal
inputs. In many embodiments, the number and arrangement of the
contacts may vary and be arranged in a number of ways. Still yet in
another embodiment, an annular configuration may be used with
n-electrodes for better signal quality and to provide other
properties such as but not limited to obtaining n-angles of the
cardiac potential. By using magnetic contacts, the monitoring
device achieves a stronger contact along the analog signal
pathways. The interface presented also provides seamless
integration between the electrode inputs and the analog front-end
circuitry. By using a magnetic ring along both the perimeter of the
multi-electrode patch and the bottom-side of the enclosure, secure
coupling is achieved. In many embodiments, the disposable electrode
side needs to be employed by magnets. In other embodiments, the
coupling is achieved by using a material with a highly magnetic
permeability such as, but not limited to an un-magnetized iron.
[0026] Another aspect of the present invention is directed to the
use of four inputs arranged on the periphery of the top-side of the
module. In many embodiments, the arrangement of the contacts may be
arranged in any manner. The contacts may be arranged in a circular,
triangular, rectangular or any other arrangement, and in several
embodiments, preferably in a parallel manner. In another
embodiment, the number of contacts may be any number greater than
two. For example, n conductive elements may be arranged around the
circumference of the device. In another embodiment, four contacts
can be used for charging and the others for use in a capacitive
touch interface. Further, the four inputs need not be magnetic.
[0027] In other embodiments, the wireless device may be positioned
at various locations throughout the body including but not limited
to the chest, shoulders, ribs, sides, back of shoulders and back.
Securement to various portions of a person's body may be by way of
clothing, bandages, adhesive patches, etc. In certain embodiments,
apparel is adapted to specifically receive the device, such as
inside a woman's bra--so that the device may be placed into contact
with the person's skin while still being unnoticeable to outside
observers.
[0028] In another embodiment, the contacts may be positioned on the
bottom surface of the device with the electrodes electrically
connected to the electronic component. The device may further be
shaped in a circular, triangular, rectangular or other desired
geometric configuration, preferably one that has a contacting
contour that is comfortable and specially adapted to rest in a
recess of a person's body so as not to be noticeable when clothing
is worn by such person. The adhesive device may include wings which
house the electrically connected electrodes. In another embodiment,
the location of the electronic components may be modified such that
all or substantially all of the electronic components are within a
housing. Wings associated with the device/housing may be provided
that are free from electronic components. In many embodiments, the
wing is more flexible than the housing. In another embodiment, the
wings and the housing are made from the same material. In other
embodiments, however, the wings and the housing are made from
different materials. Certain embodiments include wings made from a
fabric, or a synthetic fiber. As one of skill in the art will
appreciate, various materials and orientations will be appreciated
in view of the guidance provided herein, including a more detailed
description as described in U.S. Appl. No. 2011/0279962 entitled
"Device Features and Design Elements for Long-Term Adhesion"
published to Kumar et al, on Nov. 17, 2011, which is further
incorporated by reference herein.
[0029] In one embodiment of the present invention, the contacts may
be embedded into the enclosure such that they are flushed to the
surface. In many embodiments, contact exposure may vary and may be
recessed, exposed, entirely exposed, or not exposed.
[0030] In another aspect, embodiments of the present invention
provide for a DC mode configuration for the plurality (e.g. four)
of magnetic contacts. In some embodiments, configuration in an
asymmetrical configuration insures proper alignment due to the
magnetic polarities of the contacts. Further, by having a charging
sleeve and a docking counterpart with identical asymmetric
configuration, one possible fit is available providing a guide to
the user in docking the interface and the module. In another
embodiment, more than four contacts may be used. Four contacts may
be used for charging and the rest may be used for other purposes
such as a user interface.
[0031] In many embodiments, the DC mode configuration further
provides a strong magnetic force which exerts a strong interaction
between modules providing an intrinsically safe device. In many
embodiments, the inputs need not be magnetic, and other methods for
fastening the module may be employed, such methods of fastening
including but not limited to implementing a male/female grove or
notch type docking mechanism, screw or bayoneted closure features,
etc.
[0032] In another embodiment of this invention, the DC mode
configuration also provides a means for minimizing signal
interference, such means well known to those of skill in the art
and not listed herein. The static arrangement between the magnetic
contacts within the enclosure ensures signal integrity by enabling
a secure area such that the magnetic fields do not impact the
signal.
[0033] In another embodiment, the magnets may be gold plated in
order to ensure efficient charge transfer. Gold plating is a highly
stable and conducting metal. Using gold also helps prevent
corrosion caused by the exposure to various environmental
conditions. However, other conductive metals may be used, such as
silver and copper. Further, conduction may also be ensured through
the use of spring-loaded contacts.
[0034] In another embodiment of this invention, the DC mode
configuration also provides an enclosure free from environmental
restrictions. The enclosure of the present invention may provide a
means for restricting sweat, bio-fouling and other wet conditions
know to one in the art from entering the module. Other embodiments
of the present invention provide a method for charging the
monitoring device used for monitoring the patient. Upon docking
with the module, the contacts facilitate charge transfer.
[0035] In many embodiments, the plurality (e.g. four) of magnetic
contacts are used for charging at least high energy-density
batteries used in a communication system between a charger and the
device. One possible arrangement may include a cathode, an anode,
and the other two contacts may are assigned SMCLK and SMDATA roles
from a system bus protocol. This permits the incorporation of a
communication module between a charger and a module. Incorporating
such a module enables the integration of a host processor and thus
provide for additional data exchange between with the charger. The
data exchange can include but is not limited to an indication
alert. The alert can come from at least but not limited to an LED
alert, a piezo or user interface. In another embodiment of the
present invention, during the device charging the alert indicator
may be come obscured during a critical event. In still other
embodiments, the indicator can be an LCD screen or communication
device.
[0036] In certain embodiments, the communication device used as an
indicator can use other technologies to display the information
regarding the ECG reading to the user. For example, some systems
for displaying information may utilize "heads-up" displays. A
heads-up display is typically positioned near the user's eyes to
allow the user to view displayed images or information with little
or no head movement. To generate the images on the display, a
computer processing system may be used as described in U.S. Pat.
No. 8,482,487 entitled "Displaying objects on separate eye
displays" issued_to Rhodes, et al., on Jul. 9, 2013, which is
further incorporated by reference herein. In a preferred
embodiment, the "heads-up" display may be used to display patient
ECG readings. The monitoring device could communicate with a
"heads-up" display such as Google Glasses to provide the user with
additional information regarding the monitoring device. Such
information may include vitals, user profile, and even a warning if
a reading is outside the norm.
[0037] In one embodiment of the present invention, two contacts can
used as measurement electrodes and the other two may be used for
orientation purposes such as placement of an accelerometer, as
described in U.S. Pat. No. 8,460,189 entitled "Adherent Cardiac
Monitor with Advanced Sensing Capabilities" issued to Libbus et al,
on Jun. 11, 2013, which is further incorporated by reference
herein.
[0038] Further, the adherent device comprises an accelerometer and
at least two measurement electrodes. The at least two measurement
electrodes can be separated by a distance to define an electrode
measurement axis. An accelerometer signal is measured when the
device is adhered to the patient. An orientation of the electrode
measurement axis on the patient is determined in response to the
accelerometer signal. In a preferred embodiment of this invention,
the electrodes may be concentrically organized around the perimeter
of the path providing high-speed dynamic multiplexing. This
variation would allow any pair of electrodes to be selected at any
given time.
[0039] In another embodiment of the present invention, the
monitoring system may be disposable. The wireless ECG unit is
preferably implemented as an integrated adhesive disposable patch
for applying to a subject's body and for obtaining and transferring
local non-standard ECG data and standard ECG data to a receiver
unit. Alternatively, the ECG sensing unit 100 may be implemented as
reusable unit with snap connections to available disposable
electrodes. As described in U.S. Pat. No. 8,315,695 entitled
"System and method for wireless generation of standard ECG leads
and an ECG sensing unit therefore" issued to Sebelius et al, on
Nov. 12, 2012, which is further incorporated by reference
herein.
[0040] In many embodiments of the present invention, the patient
monitoring system may be reusable with disposable parts, reusable,
or completely disposable.
[0041] In another aspect of the present invention, the monitoring
device may be configured to include a user interface. The magnetic
contact configuration can be used by doctors in order to retrieve a
patient's information by means of a scroll wheel. The magnetic
contacts preferably serve as a multi-input capacitive touch
user-interface and even more preferably the magnetic contacts are
positioned at various locations as the wheel is adjusted, providing
for varying services including but not limited to patient's
records, ECG data and other menu items.
[0042] In one embodiment of the present invention, the multi-user
interface functions and works as a locking mechanism. The use of
the scroll wheel provides a safe means for locking the device which
avoids accidental triggers. The scroll wheel works similar to that
of a pattern-lock on a smartphone. That is to say, the wheel has to
be rotated in a series of directions (i.e. 2 turns clockwise, 1
counterclockwise) to enable patient input. In many embodiments of
the present invention, the number of contacts vary, increasing the
number of patterns that may be added. In one embodiment, the user
input screen may be configured to time-out after non-used for a
predetermined number of minutes.
[0043] In another embodiment, the capacitive touch device maybe
directed to the use of the interactive scheme in which the
monitoring device may be wirelessly controlled by a peripheral
communication device. Such communication device may include but not
limited to a laptop, tablet, smartphone, etc. Such external
connectivity provides further control and customization the device.
The user may now have access to dynamic switching, zooming and
programming (i.e. entering user data, network info, selecting menu
options, etc.)
[0044] In another embodiment, the adherent device may continuously
monitor physiological parameters, communicate wirelessly with a
remote center, and provide alerts when necessary. The system may
comprise an adherent patch, which attaches to the patient's body
and contains sensing electrodes, battery, memory, logic, and
wireless communication capabilities. In some embodiments, the patch
can communicate with the remote center, via the intermediate device
in the patient's home. In some embodiments, remote center receives
the patient data and applies a patient evaluation algorithm, for
example an algorithm to calculate the apnea hypopnea index. When a
flag is raised, the center may communicate with the patient,
hospital, nurse, and/or physician to allow for therapeutic
intervention as described in U.S. Pat. No. 8,460,189 entitled
"Adherent Cardiac Monitor with Advanced Sensing Capabilities"
issued to Libbus et al, on Jun. 11, 2013, which is further
incorporated by reference herein.
[0045] The adherent device can wirelessly communicate with a remote
center. The communication may occur directly (via a cellular or
Wi-Fi network), or indirectly through an intermediate device. An
intermediate device may consist of multiple devices, which can
communicate wired or wirelessly to relay data to a remote
center.
[0046] In another embodiment, the adherent device can communicate
with a remote center via an Epidermal Communication Network (ECN).
The epidermal communication network is a novel communication
network, method, and protocol that enables data from the adherent
device, external device, interface module, etc., to be transmitted
across the epidermal layer of the body. Because electrons can
travel across a medium when a potential difference in energy or
voltage is present, and the human body is capable of holding
potential differences across its frame, the epidermal layer of the
body can be used to carry electrical signals. The physical
properties of the epidermal layer provide a medium which allows
electrical signals to directly interface and/or be applied to the
epidermal layer of the human body, which is well suited to carry
signals along the exterior surface. By treating the human body as a
conductor, the body acts as a physical wire connecting one or more
devices and allows data to be transmitted and received by the
devices. Therefore, if an electrical signal is directly applied to
the human body, it is possible to read/measure the potential
difference at a point in the body. Further, data can be digitized
onto the human body and stored until needed, allowing the body to
act like a storage medium, much like, but not limited to, a flash
drive, hard drive, RAM, ROM, DRAM, SDRAM, and other storage devices
and media.
[0047] In one embodiment, the signal can travel through the body
and a signal handling device can be used. As appreciated in view of
the guidance provided herein, including a more detailed description
as described in U.S. Pub. No. 2014/0348270 entitled "Handling of
Signals Transmitted Through a Human Body" to Badu et al. on Nov.
27, 2014, which is further incorporated by reference herein,
various combinations of signal transmission and wearable devices
are within the scope of the present invention.
[0048] In many embodiments, the capacitive touch user interface can
be configured to take ECG measurements. In another embodiment, the
interface provides the user with a confirmation and verification of
the signal integrity used in the ECG measurement. In emergency
situations where signal integrity is critical, doctors need to have
access to signals with minimal affects due to noise or distortion.
To accomplish this, the signal inputs are routed through an analog
multiplexer to the analog to digital converter inputs. These inputs
are by nature very high impedance (just as primary electrodes on
the reverse side of the device) and thus may be considered passive
such that there is no danger presented to the patient. Such dangers
include but are not limited to a short-circuit potential. To
confirm signal integrity, a Lead I measurement is taken. A standard
Lead I is a differential measurement that is comprised of the
voltage measurement at the left arm with respect to the voltage
measured at the right arm. In using the interface, this measurement
is accomplished by placing a finger from the left hand is placed
onto the designated contact for Left-Arm, and two fingers from the
right hand are placed onto a designated contacts for Right-Arm and
Right-Leg Drive. This results in Lead I ECG waveform. In another
embodiment, a standard Lead II may be measured by taking the
voltage differential at the right arm with respect to the voltage
measured at the left leg. Still in another embodiment, a standard
Lead III may be measured by taking the voltage differential at the
left arm with respect to the voltage measured at the left leg. In
many embodiments, the number of contacts needed for signal
verification could vary in number with a minimum of one contact
required. Simple heart--rate detection may be accomplished with one
magnetic contact.
[0049] In one embodiment, an electrical conductive strap or garment
system is used to allow communication between wearable electronics.
The electric conductive garment can be a strap, a tie, a fastener,
a strip, clasp, a clip, a pin, a button, a zipper, a belt, and any
other securing mechanism that can be used. The conductive strap can
be used to power electronic devices. In one embodiment, the
communication between the wearable sensors can be entirely through
conductive threads, fabrics, etc. linking the sensors through the
wearable garment. In other embodiments, the conductive strap can
further work in conjunction with other communication mediums such
as wired, wireless, and ECN communications. As one of skill in the
art will appreciate, various applications, methods, and systems for
communicating between wearable devices is possible. As appreciated
in view of the guidance provided herein, including a more detailed
description as described in U.S. Pat. No. 6,350,129 entitled
"Wearable Electronics Conductive Garments Strap and System" issued
to Gorlick et al. on Feb. 6, 2002, which is further incorporated by
reference herein, various combinations of the wearable devices are
within the scope of the present invention.
[0050] In another embodiment of this invention, the monitoring
device with capacitive touch user interface may also be equipped
with smart detection hardware. The hardware is able to recognize
various interactions with the device and adjust accordingly. For
example, if the device is being worn in a noisy environment, the
device may auto-correct itself to accommodate by adjusting its
capacitive input baseline and threshold parameters. In many
embodiments, the smart detection hardware may be configured to
intelligently switch to allow for charging. In another embodiment,
a required check is necessary to verify that the charger and the
host are ready for charging, thus eliminating accidental discharge
or a short circuit. In another embodiment, the charging pathway is
physically disconnected from the external output (unless the above
referenced check has been detected, in such case, charging may
commence.
[0051] In many embodiments, the capacitive touch interface may be
dispensed and replaced with a touch-based OLED display.
[0052] In another aspect of the present invention, the use of a
human body as a signal transmission path can be incorporated such
that the system includes a transmitter and a receiver. The signal
can be carried through a path extending though the human body when
a user carrying a transmitter touches the electrodes of the
receiver. Various embodiments are possible, as will be appreciated
in view of the guidance provided herein, including a more detailed
description in U.S. Pat. No. 6,864,780 entitled "Data Transmission
System using a Human Body as a Signal Transmission Path" issued to
Doi on Mar. 8, 2005 and U.S. Pat. No. 6,771,161 entitled "Data
Transmission System Using a Human Body as a Signal Transmission
Path," issued to Doi et al, on Aug. 3, 2004, which are further
incorporated by reference herein. In other embodiments, the
receiver is not integrated into the external devices. Instead, a
system on a module is proposed such that external devices can be
incorporated and can still communicate with its own system. In
still other embodiments, the use of biosensors can be used in
conjunction with the data transmission system. Also, third party
biosensor systems can work with the use of an interface in order to
provide communication on the body using the data transmission
system.
[0053] In still another aspect of the present invention, the use of
the body for signal communication is presented without the use of
an earth ground. Instead, the ECN can transmit and receive signals
by conditioning an AC signal and coupling the signal on the
epidermis of the body. Conditioning the signal can include
modulation and amplification in order to increase the drive
capacity of the signal in light of the resistive and capacitive
load of the epidermis. Resonant networks that can be used include,
but are not limited to LC resonant (both series and parallel),
ceramic resonators, crystals, IC resonators and the combination
thereof.
[0054] In another aspect of the present invention, device charging
can occur by means of an inductive mechanism. In many embodiments,
a charging coil may be integrated into the exterior of the device
enclosure. The embedded coils used in this inductive charging
scheme are wound concentrically around the sleeve of the enclosure.
In another embodiment, the coils may be located outside the sleeve
on the outer perimeter of the top surface, or anywhere on the
device surface or in any arrangement on the sides of the module. In
another embodiment of the invention, inductive charging is
available while the four contact mediums are still present. In this
configuration the inductive coils perform the charging, while the
four contacts are utilized to ensure firm attachment between the
device enclosure and the charging sleeve. The four contacts do not
participate in charging the monitoring device in this
configuration. Still in another embodiment, the contacts could also
participate in the charging. In inductive charging, the outputs
from the sleeve pass through the transmitter coil. The charging
current which is coupled onto the receiving coil where it is
rectified and conditioned to charge the smaller capacity on-board
battery. In another embodiment, a modulator is applied such that
the information may be transmitted between the charging unit and
the device.
[0055] By implementing the inductive charging scheme with the
integrated coil, the need for attachment of an external power
source is eliminated. Instead, this scheme permits the user to
recharge the device while in use. Further, because the battery is
on the sleeve of the enclosure, it maybe recharged using standard
DC-charging methods. To ensure that the device side is fully
charge, a higher-capacity lithium-polymer battery on the charger
side is preferred.
[0056] In another aspect of the invention, the device is
batteryless. Through the process of energy harvesting, the wearable
device is powered from external sources. In general, energy
harvesting is the process by which energy from various sources such
as, but not limited to, solar energy, thermal energy, wind energy,
and kinetic energy, is collected and used to power the wearable
device. Rectennas as well as antennas can be implemented in the
device for ambient, harvesting as well.
[0057] In other embodiments of the invention, the human body can be
used as a proximity sensor. Upon user input and once proximity is
established, data transfer can take place by a wireless medium.
Proximity sensing permits communication with another device for the
purpose of reducing the energy consumption, thus, enabling the
possible use of a batteryless device. In one embodiment, the human
body communication system includes a controlled device measuring a
capacitance that corresponds to the distance to human body, i.e.
proximity sensing, which can then use the human body as a medium
for transmitting a control command through the body. A wireless
medium then transmits the actual data as described in U.S. App. No.
2007/0190940 entitled "System and Method for Human Body
Communication" published to Lee et al, on Aug. 16, 2007, which is
further incorporated by reference herein. Additionally, the method
used in proximity sensing can include controlling the transmit
power as described in U.S. Pat. No. 8,457,571 entitled "Apparatus
and Method for Controlling Transmit Power in Human Body
Communication System" to Kim et al, on Jun. 4, 2013, which is
incorporated by reference herein. Further, the communication
apparatus used for data communications using the human body as the
transmission channel described in U.S. Pat. No. 8,224,244 entitled
"Communication Apparatus" to Kim et. al, on Jul. 17, 2012 is
incorporated by reference herein.
[0058] In other embodiments, an intelligent communication scheme is
employed wherein human input is not required and proximity sensing
and/or communication is dictated by the microcontroller itself.
Communication occurs seamlessly without user input required.
[0059] In still another embodiment, there is no need to measure
signal power or reliance on body proximity. Instead, the human body
is used as the communication medium, as the information is
transmitted on the epidermal layer of the body.
[0060] In yet another embodiment, the device can be ECN enabled. An
ECN enabled device is a device with the ability to communicate via
the epidermal communication network. By having a device which can
communicate using an ECN, a drastic reduction in power consumption
is observed as it pertains to inter-device communication on a human
body. Thus, the energy savings can provide for a device that uses
less power and is batteryless. As such, an ECN enabled device also
has the capacity to use energy harvesting techniques to power up
and function properly.
[0061] In other embodiments, the device is ECN enabled through the
use of an ECN interface. An ECN interface, is an interface that
permits users to interact with other smart devices via the ECN. By
docking a device (such as the remote center) on an ECN interface,
communication on the ECN is enabled, permitting transmission and
reception of data to and from the wearable device via the human
network. This communication can result in tremendous power savings,
and may enable the use of devices powered using energy harvesting
methods.
[0062] In other embodiments, an entire "smart device" is created on
a module that also provides for access to communication on the ECN.
The internal operation can be abstracted such that only the data
I/O and control pins are exposed and an ECN interface is designed
to fit the module. Such module/interface device can also, much like
with the other ECN enabled devices described above, provide large
power savings as compared to other communication alternatives such
as, but not limited to, Bluetooth, BLE, ZigBee, Wi-Fi, WLAN,
etc.
[0063] In one aspect of the invention, the monitoring device is
used in monitoring applications where the sensors are located at
various locations around the body. The various configurations
account for varying differential voltage inputs. In one embodiment,
the monitors may be used to monitor two independent heart beats.
For example, the wireless electrocardiogram of a mother may be
referenced and used in conjunction with a fetus to monitor fetal
cardiac activity.
[0064] In one embodiment, a plurality of sensors can be used in
body-coupled communications. In another embodiment, the plurality
of sensors can transmit signals in conjunction with personal area
networks (PAN) and/or Near-Field Intra-Body Communications.
Communication signals transmitting on PAN or NFC work at RF
frequencies. Still in another embodiment, a plurality of body
coupled communication signals which have been detected via a
plurality of electrodes can be used to generate a diversity output
signal as described in U.S. Pat. No. 8,633,809 to Schenk et al.,
entitled "Electrode Diversity for Body-Coupled Communication
Systems, on Jan. 21, 2014, which is further incorporated by
reference herein.
[0065] In another embodiment, the body-coupled communication system
can include only one electrode and thus uses only one transmission
path for data transfer. In yet another embodiment, the body-coupled
communication system works at very low frequencies requiring less
signal processing and providing many-fold power savings.
[0066] In making ECG measurements, timing is of paramount
importance; even a few milliseconds in delay may lead to a severely
distorted reading. In ECG applications, exact timing is essential.
Of primary concern is the fact that the human heart operates on a
time scale that is much slower than the operating F of digital
circuits. Therefore, in order to obtain accurate readings, even
though electrodes are spaced apart, the measurements must be made
simultaneously. To accomplish this, the electrodes are connected to
an analog-to-digital converter, which uses a common clock and
reference potential. The measurement taken is then a bipotential
measurement.
[0067] In another aspect of the present invention, the monitoring
device used at various locations in the body is synchronized to a
reference to enable accurate measurements. In one embodiment of the
present invention, a synchronized frame may be used in conjunction
with the ADC and common clock to make the bipotential measurement.
In one embodiment of the present invention, a crystal oscillator
can be used for synchronization. The crystal oscillator generates
the clocking signal. In another embodiment of the present
invention, the RC oscillators may be used since they are less
costly and consume less energy. Yet still in another embodiment of
the present invention, a wireless synchronization frame is used. In
many embodiments, wireless synchronization frames may be used with
oscillators to correct time lag between sensors.
[0068] In one embodiment, complete wireless synchronization between
units is presented. Synchronization between two separately located
sensors is possible through the use of master-slave model. In this
embodiment, one of the sensors plays the role of the master and one
or more sensors act like slaves, synchronizing to the master. In
one embodiment, a slave sensor may contain substantially less
hardware than the master. In other embodiments, the slave may be
much smaller in size than the master. The master sensor can
combine, filter and analyze data collected and relayed from the
slave sensors. The input data gathered by the slave sensors is
transmitted wirelessly to the master sensor.
[0069] In a preferred embodiment, a unified synchronous clocking
system between a master-slave network is presented. In this scheme,
the clock signal is coupled to the patient allowing all the sensors
to synchronize directly to this signal. The master device generates
a stable low-frequency AC signal lying outside the frequency
bandwidth of interest for measurement and drives this current into
the patient's body via an output electrode. This output might also
double as the right-leg drive output. The current output to the
patient is of low enough frequency and magnitude to be completely
benign to the patient (e.g. similar to transmission line coupling,
or the RLD). This signal is thus accessible to all of the sensors
in the network and servers as a unified reference clock input
amongst devices. In order to generate the high clock rates needed
for data-capture, processing, and wireless transmission (wireless
transmission may require its own dedicated clock for practical
purposes), the reference clock is used as the input to a phase
locked loop multiplier onboard each sensor to generate high
frequency clock signals within each device. Once each slave on the
network is synchronized to the master-issued clock signal coupled
onto the patient, frequency drift between devices is eliminated. By
eliminating the frequency drift, the measurements are made
simultaneously so that in the standard Lead I measurement, the RA
and the LA measurements are preserved. Measurements of the signals
of interest are unaffected by the presence of this signal as it
will appear as a common-mode signal on differential input
amplifiers or alternatively may be removed via a low pass filter.
Further synchronization of data-sampling events may be enabled
through modulations of the master-output clock signal which may
serve as interrupts to cue data acquisition.
[0070] In order to obtain a potential measurement using this
unified synchronous clocking network scheme, data from the
analog-to-digital converters is loaded to the registers of a
processor. The processor may be a microcontroller. This is possible
by configuring the inputs as single ended inputs such that the
measurement are made relative to identical high reference voltage
on each device. The master device may then produce bipotential
measurements across pairs of sensors by polling each device in the
slave network. In many embodiments, at periodic intervals,
reference frames may be inserted into the data in order to
facilitate the combination of the single-ended inputs at the master
prior to streaming wirelessly.
[0071] Still another aspect of the present embodiment, involves the
use of an ECN network to obtain the ECG potential measurements.
Potential measurements can be obtained by use of the epidermal
communication network, wherein transmission and reception of data
between devices using ECN facilitate measurements with more
accuracy and simplified synchronization. In general, the
communication between the wearable device and the smart device,
internal device, ECN interface, etc. (i.e. remote center) entails
the following. First, the raw data is sent, modified and/or a
combination of both onto the epidermis via a slave/master. Next,
the modified/raw data is received via the epidermis by the
master/slave. Finally, if the data was modified, the inverse
function is applied to yield the original raw data (i.e. the
potential measurements). The simplest scenario is the direct input
and/or output of the raw binary data onto the epidermal layer. In
another scenario, the data requires at least one of encoding,
modulation, conditioning, encryption and other signal
processing.
[0072] In some instances, such as in ECG, Full 12-Lead ECG, and/or
EEG potential measurements, conditioning, measurements and
digitizing does not occur until the raw data arrives at the output,
or other location of the body. The raw physiological signals are
amplified, modulated/demodulated and sent without digitizing. By
using an operational amplifier, the raw signal is amplified against
a stable common reference, which affords a simple low cost solution
without the use a microcontroller. The amplified signal is used as
a gating/base input on a transistor with emitter/source pull to
ground. Concurrently, an oscillator supplies the drain/collector
input to the transistor, which leads to a modulated signal at the
oscillator's frequency. This method permits the assignment of a
unique carrier frequency to the inputs which allows differential
measurements to be made as the signal is located by the "master"
sensor located elsewhere in the epidermis.
[0073] An exemplary embodiment of this protocol implementation
includes presetting the Master to a "ping frequency." The Master
listens for the ping frequency on a predefined time interval on a
reoccurring basis. A newly powered slave transmits this ping
frequency which the Master then receives. Upon reception, the
Master assigns a new "address frequency" to the slave, who in turn
stores it in memory. The slave and Master communicate, (i.e. the
system is now ECN enabled), as the Master recognizes the address
frequency and the slave receives its own frequency. The direct
amplification allows for wireless/leadless measurement of data from
different locations on the body to be taken simultaneously and
continuously without interfering with each other. Once the
different signals (i.e. LA, RA, LL, etc.) are detected by the
Master, the signals can be demodulated and fed to the remote
center, or other device for generating the Lead data.
[0074] In another embodiment, synchronization on the epidermal
communication network can occur via synchronous and/or asynchronous
communication methods. Synchronous transmission entails
synchronization by an external clock, while asynchronous
transmission synchronizes by signals along the transmission medium.
As previously stated, transmission on the ECN simplified
synchronization over other embodiments. Because there is no clock
signal accompanying the data on the epidermis, asynchronous methods
can easily be adapted for ECN. In general, data-rates and
arbitration can be processed prior to data transmission allowing
one node to occupy the bus at a given time. In some embodiments,
more than one node can occupy the bus at a given time. A
predetermined arbitration scheme (protocol) can be employed to
facilitate communication between a network of sensors on the
epidermal bus. Time-division multiplexing, Frequency Division
Multiplexing, Code Division Multiplexing, and/or Space Division
Multiplexing can also be used. Additional system communications
techniques are also possible, such as but not limited to,
full-duplex communication and simultaneous asynchronous
communication.
[0075] Synchronous communication, such as but not limited to, I2C,
SPI, SDIO, etc. can also be implemented on the ECN. For synchronous
communication, frequency mixing techniques can be employed, wherein
specific frequency signatures would be assigned to the individual
channels. Furthermore, both serial and parallel communication
protocols can be adapted for communication on the ECN.
[0076] In another aspect of the present invention, the medical
practitioner, nurse, technical assistant, cardiologist, etc., can
use an ECN enabled sensor to obtain immediate access to a patient's
vitals, records, and other medical and/or personal information. The
user retrieving the information can obtain a patient's differential
measurements through touch of the patient. That is, a patient's ECN
is used to transfer the information from the ECG Lead sensors onto
an ECN enabled sensor worn by the clinician.
[0077] In some embodiments, the clinician can use a wearable
mounted display such as smart glasses to gather the information via
the ECN. In this embodiment, the clinician and/or doctor can use
smart glasses that are ENC enabled, to project information from and
about the patient onto the screen of the eyeglass. Transmission
between the patient and eyeglass can occur by patient touch through
the ECN, wireless transmission, a wired transmission, and/or a
combination thereof.
[0078] In another embodiment, the ECN enabled sensor from above can
be a smart watch. The smart watch with for example, an LCD screen
can be used to read a patients information. The smart watch can
project the information read through the ECN onto the LCD screen.
The smart watch can also be used to sense and monitor other
relevant factors of a person and in conjunction with one or more
other wearable devices for transmitting/receiving information. The
epidermal communication network can work in conjunction with
multiple smart devices. As an example, the smart watch can be used
for taking a person's vitals such as temperature, hydration levels,
blood pressure, sugar level, etc. Alternatively, the watch can be
used in conjunction with other devices such as a ring or other
piece of jewelry to monitor a person's oxygen level like in pulse
oximetry. The finger is already known as an excellent location for
SP02 measurements, thus, 2 LEDs can be incorporated on one side of
the ring for the purposes of measuring blood oxygenation. The data
is sent via an ECN to a master device such as or in conjunction
with the watch or other device for further processing, display, or
wireless communication. In other instances, watch and earring or
other device can be used for hearing tests and/or hearing aids.
[0079] In one embodiment, the monitoring device or sensor can
include a unique patient ID and telemetry system. The monitoring
device includes ID circuitry that includes ID storage, a
communication system which reads and transmits the unique ID from
the ID storage, a power source and a pathway system to route the
signals through the circuitry described in U.S. patent application
Ser. No. 13/923,543 entitled "System Using Patient Monitoring
Devices with Unique Patient ID's and Telemetry System" published to
James Proud on Oct. 24, 2013 which is further incorporated by
reference herein. In another embodiment, the monitoring device is
ECN enabled and communicates via the epidermal communication
network.
[0080] In another embodiment, the ECN network can work for and with
one or more smart devices that are not the smart watch such as, but
not limited to, a ring, a necklace, earrings, a money clip, a hair
piece, buttons on a shirt, nose/eye/tongue ring, etc. Further, the
ring for example, can be used not only for monitoring a patient's
vitals, but can be used as a replacement or in conjunction with a
wireless or wired mouse and/or combination thereof. In yet another
embodiment, the ring can use motion, spatial and/or the combination
thereof tracking by way of sensors such as but not limited to
acoustic, electric/magnetic, location, pressure, thermal, and other
smart sensing.
[0081] In one embodiment, the ring can act as a temperature
monitoring device as described in U.S. Pat. No. 8,663,106 entitled
"Non-Invasive Temperature Monitoring Device" published to Stivoric
et al., on Mar. 4, 2014, which is further incorporated by reference
herein. In another embodiment, the temperature monitoring device is
ECN enabled and communicates via the epidermal communication
network.
[0082] In other embodiments, the wearable sensors can be attached
to a child's diapers. The sensor on the diaper can be used for
monitoring a wet child, recording vital signs and even detecting
more serious conditions such as S.I.D.S. The sensor can work in
conjunction with the ECN network, a wireless network, a wired
network, and/or a combination thereof.
[0083] The use of the ECN with other smart devices can include ECN
enabled devices, wearable devices/sensors, wired devices, wireless
devices, devices with ECN enabled interface, etc. Devices with an
ECN Enabled Interface can include any device that works in
conjunction with an attachment, software or combination thereof
that allows the device to interact with ECN enabled wearables. The
attachment, software, etc. is the interface that is incorporated
into the existing device to allow the interaction on the epidermal
communication network.
[0084] In another aspect of this invention, the ECN can be used as
a means for transporting and/or facilitating the movement of
information/data between various smart devices. For example, the
ECN can be used to upload/download personal information onto a
wearable device and/or external device. The wearable device can
include, but is not limited to, a smartwatch, wrist-band, adhesive
patch, garment, rings, smart glasses, necklace, etc. The external
device can include a computer, laptop, smart phone, projector,
scanners, and other such devices which may or may not include
encryption which are or are not ECN enabled or interfaced.
[0085] Personal information and identification (i.e. credit card
information, demographic information, login credentials, digital
signatures, medical history and conditions, etc.) can be uploaded
directly onto the wearable device via user interaction with the ECN
enabled interface and stored on the wearable device memory. The
information can be retrieved and downloaded at any time through
touch with or interaction with other ECN enabled or interfaced
devices. For example, a user may upload and store credit card
information on an ECN enabled wearable (such as a wrist band) with
an associated ECN Enabled Interface payment device tag, store the
information, and later touch the payment interface at a venue, such
as but not limited to a retail shop, airport, sporting arena, mall,
coffee shop, etc., for access to the credit card information and
other contents associated with the tag. Thus, a user is purchasing
items and accessing his/her payment information by way of touch
through the ECN network, which can replace and/or work in
conjunction with RFIDs, QR codes, NFC communications, etc.
[0086] In many embodiments, information such as social security
numbers, passwords, bank information, etc., requiring encryption
and/or other security measures can be downloaded by requiring for
example, a fingerprint scan in addition to the venue ECN
enabled/interface device. In addition, encryption can be added to
retrieve the secure information. Encryption can be enabled and the
information retrieved by providing an encryption key assigned to a
master sensor, which only the master sensor can retrieve. As an
example, 128 AES encryption can be utilized. In still another
embodiment, the fingerprint, encryption key and special ping
frequency may be required to retrieve the secure information.
Further, a fingerprint scan, multiple fingerprint scan, eyeball
scan, and/or a combination thereof can be used alone or in
conjunction with the above mentioned security measures.
[0087] In other embodiments, the user information can be encoded
and used to unlock or enable consumer electronics. For example, a
personal identification can be stored and used to open a garage
door, enable the A/C, lock/unlock a door, unlock a smart phone,
pair with an ECN enabled printer, automatically connect to a
network access point, route directions from/to a navigation system,
email accounts, Google accounts, etc.
[0088] In another embodiment, the ECN can be used for file transfer
between devices. Files can include, but are not limited to
pictures, videos, data structures, word documents, picture art,
html files, XML files, etc. For example, a file containing user
data on a health/fitness machine can be stored on a wearable device
and accessed using the ECN. In another embodiment reading from the
wearable device can be directed to health/fitness logs,
measurements, monitoring, etc. The health/fitness/heart rate logs
can occur using at least a photoplethysmographic sensor. The use of
the photplethysmographic sensor can be include a periodic light
source, a photo detector and other modules and/or components as
described in U.S. Pat. No. 8,956,303 entitled "Wearable Heart Rate
Monitor" issued to Hong et al. on Feb. 17, 2015, which is
incorporated by reference herein.
[0089] In another example, a phone with an ECN enabled interface
could upload data onto a small memory chip residing on a sensor
and/or patch. Data is encoded over the ECN and stored until the
user interacts with the intended device. Therefore, driving
directions can be downloaded from a smart phone to an automobile
navigation system with the use of the ECN patch and/or through an
ECN enabled interface. Thus, the data file with directions is
transferred from smart device to another without the need for
Bluetooth or Wi-Fi connectivity.
[0090] In one aspect of the present invention, the ECN can work in
conjunction with ingestible sensors for monitoring
bio-electrochemical processes. By encapsulating an IC, testing and
detection of malignant matter in a user can be detected. For
example, the ingestible sensor can be used for detection of
pathogens, cancers, toxins, antibodies, viruses, etc.
Alternatively, the ingestible sensor can be used to test for
chemical reactions to medications and treatments and even system
responsiveness or in connection with ECG measurements. The
ingestible sensor can work in conjunction with an epidermal
communication network through near-field coupling, as a
stand-alone, or with other wired or wireless systems, devices,
networks and protocols.
[0091] In one embodiment, the ingestible sensor is swallowed and
configured to receive stimulus inside the gastrointestinal tract of
the user as described in U.S. patent application Ser. No.
11/851,221 entitled "Ingestible Low Power Sensor Device and System
for Communicating with the Same" published to Amerson et al., on
Jun. 19, 2008, which is further incorporated by reference
herein.
[0092] In aspect of the present invention, the monitoring device is
used to provide apparatus which will continuously monitor and
analyze EKG or ECG signals generated by an ambulatory patient,
diagnose abnormal events and instruct the patient on the manner of
treatment required. In one embodiment, the present invention is to
provide a portable computerized EKG monitor for performing
real-time analysis of EKG signals to recognize and diagnose
myocardial ischemic conditions and thereupon to immediately issue
instructions for treatment or other action to the ambulatory user
himself. In many embodiments, the device monitor can be a portable,
lightweight computer which performs continuous real-time analysis
of EKG information to detect, and alert an ambulatory user of,
ischemic conditions, including the silent or pre-symptomatic type
as described in U.S. Pat. No. 4,679,144 entitled "Cardiac signal
real time monitor and method of analysis" issued to Cox et al. on
Jul. 7, 1984, which is further incorporated by reference herein. In
a preferred embodiment, the monitoring device is designed is
wireless enabling the ambulatory personnel easier manipulation
without the cumbersome use of wires while riding at high speeds.
Still in another embodiment, the device monitor provides a means
for wireless charging. The device may be configured to include a
DC-mode or inductive mode charging such that in an emergency, power
is not an issue.
[0093] In another aspect of the present invention, the device
monitor may be configured for extended use. In many embodiments,
the monitor is configured for patient comfort, such that the device
can be worn and tolerated for extended periods of time. In one
embodiment, a self-contained, wearable, portable ECG monitor is
attached to the patient as described in U.S. Pat. No. 8,150,502
entitled "Non-Invasive Cardiac Monitor and Methods of Using
Continuously Recorded Cardiac Data" published to Kumar et al, on
Apr. 3, 2012, which is further incorporated by reference
herein.
[0094] The watertight chamber comprises separate watertight
enclosures around each electrode of the at least two electrodes. A
port for electronically accessing the electronic memory and a seal
is provided on the port. The seal may be formed by the housing. In
another embodiment, there is provided an activation or event
notation button or switch formed in the housing that is accessible
while the adhesive is affixed to the mammal. In one embodiment,
actuation of an activation or event notation button or switch
increases the fidelity of the ECG information stored in the
electronic memory. In another embodiment, an indication of
activation or event notation button or switch activation is stored
in the electronic memory with contemporaneous ECG information. In
yet another embodiment, there is provided an indicator that
activates when ECG of the mammal is being detected. In another
aspect, an indicator is provided that provides a continuous
indication as long as ECG of the mammal is detected. In another
embodiment, an indicator is provided that activates when a
monitoring period is completed. In another embodiment, at least a
portion of the housing is colored to match the skin tone of the
mammal, or contain a decoration, art work, design, illustration or
cartoon character to provide a custom appearance to the device. In
a preferred embodiment, the watertight chamber includes a scroll
wheel which enables the user to access the patient's information,
ECG readings and other information acquired regarding the patient's
vitals.
[0095] In another aspect of the present invention, a wireless heart
rate monitor like device may be used to monitor a patient's cardiac
state. The conventional heart rate monitor device consists of a
chest strap sensor-transmitter and a wristwatch-type receiver. The
chest strap sensor is worn around the chest during exercise. It has
two electrodes, which are in constant contact with the skin, to
detect electrical activities coming from the heart. Once the chest
strap sensor-transmitter has picked up the heart signals, the
information is wirelessly and continuously transmitted to the
wristwatch. The number of heart beats per minute is then calculated
and the value displayed on the wristwatch. Strapless heart rate
monitors are typically wristwatch-type devices that may be
preferred by users engaged in physical training because of
convenience and combined time keeping features. In some cases the
user is required to press a conductive contact on the face of the
device to activate a pulse measurement sequence based on electrical
sensing at the finger tip. However, this may require the user to
interrupt physical activity, and does not always provide an
"in-process" measurement and, therefore, may not be an accurate
determination of heart rate during continuous exertion.
[0096] There are 2 sub-types of strapless heart rate monitors. The
first type measures heart rate by detecting electrical impulses.
Some wristwatch-type devices have electrodes on the device's
underside in direct contact with the skin. These monitors are
accurate (often called ECG or EKG accurate) but may be more costly.
The second type of monitor measures heart rate by using optical
sensors to detect pulses going through small blood vessels near the
skin. These monitors based on optical sensors are less accurate
than ECG type monitors but may be relatively less expensive. In a
preferred embodiment, the wrist watch-time device may also
communicate with another external device to provide a patient's
vitals and may self-charge with the use of a DC-mode
configuration.
[0097] In another aspect of the present invention, the monitoring
device may be attached to a person's garment. The device connects
to the garment by attaching or integrating one or more of the
sensors into the garment, as described in U.S. Pat. Appl. No.
2012/0165645 entitled "System Method and Device for Monitoring
Physiological Parameters of a Person" published to Russell et al.
on Jun. 28, 2012, which is further incorporated by reference
herein. The monitoring device comprises a bottom portion and a top
portion that mate together to house an internal portion that
comprises a processor, electronics, one or more transceivers, one
or more light emitting LEDs. The bottom portion may include leaf
springs (or other sensor pads) that conduct data from a plurality
of sensors in or attached to the garment to the electronics (e.g.,
an ADC, DSP, or processor) of the internal portion. In another
embodiment of this invention, the mobile device may include an OLED
to alert in case of irregular potential reading. Still in another
embodiment, the garment sensor may include an LCD screen in order
to facilitate device interaction with other mobile devices.
[0098] In another aspect of the present invention, the monitoring
device may be attached to a person's earphone. The device connects
wirelessly or by wires to the ear of a human as described in U.S.
App. No. 2014/0243617 entitled "Wearable Apparatus for Multiple
Types of Physiological and/or Environmental Monitoring" published
to LeBoeuf et al., on Aug. 28, 2014 and U.S. App. No. 2014/0243620
entitled "Physiological Monitoring Methods" published to LeBoeuf et
al., on Aug. 28, 2014, which are further incorporated herein by
this reference. A method for monitoring a subject via an earbud
module includes positioning the earbud module within the ear of the
person such that a sensor region matingly engages a region of the
ear at the intersection of the anti-tragus and acoustic meatus and
is oriented in a direction away from the ear canal. Further, the
wearable apparatus can be used for monitoring various physiological
and environmental factors. Real-time, non-invasive health and
environmental monitors include a plurality of compact sensors
integrated within small, low-profile devices. In another
embodiment, the earbud modules can work outside the ear, as part of
an earring, attached to both or one ear, etc. In one embodiment,
the earbud module can work in conjunction with other wearable
devices or sensors for monitoring. Still in another embodiment, the
earbud monitor can communicate wirelessly, through a wired medium,
and/or the ECN.
[0099] It may be appreciated that many applications of the present
invention may be formulated. One skilled in the art may appreciate
that a network may include any system for exchanging data or
transacting business, such as the Internet, an intranet, an
extranet, DSL, WAN, LAN, Ethernet, satellite communications, and/or
the like. It is noted that the network may be implemented as other
types of networks, such as an interactive television (ITV)
network.
[0100] A system user may interact with the system via any input
device such as, a keypad, keyboard, mouse, kiosk, smart phone,
e-reader, tablet, laptop, Ultrabook.TM., personal digital
assistant, handheld computer (e.g., Palm Pilot.RTM.,
Blackberry.RTM., iPhone.RTM., iPad.RTM., Android.RTM.), cellular
phone and/or the like. Similarly, the invention may be used in
conjunction with any type of personal computer, network computer,
work station, minicomputer, mainframe, smart phone, tablet, or the
like running any operating system such as any version of Windows,
MacOS, iOS, OS/2, BeOS, Linux, UNIX, Solaris, MVS, tablet operating
system, smart phone operating system, or the like, including any
future operating system or similar system. Moreover, although the
invention may frequently be described as being implemented with
TCP/IP communications protocol, it should be understood that the
invention could also be implemented using SNA, IPX, Appletalk,
IPte, NetBIOS, OSI or any number of communications protocols.
Moreover, the system contemplates the use, sale, or distribution of
any goods, services or information over any network having similar
functionality described herein.
[0101] By way of providing additional background, context, and to
further satisfy the written description requirements of 35 U.S.C.
.sctn.112, the following references are incorporated by reference
in their entireties for the express purpose of explaining the
nature of ECGs, wireless sensors and other devices and to further
describe the various apparatuses commonly associated therewith:
[0102] U.S. App. No. 2008/0177198 to Jang et al, discloses an
apparatus to measure skin moisture content, that apparatus
including: an electrode unit comprising a reference electrode, a
current electrode, and a measuring electrode; an optional amplifier
having an inverted input terminal connected with the R
electrode.
[0103] U.S. Pat. App. No. 2012/0165633 to Khair, discloses a
leadless wireless ECG measurement system for measuring of
bio-potential electrical activity of the heart in a patient's body
includes at least one multi-contact bio-potential electrode
assembly adapted for attachment to the patient's body. The
electrode assembly is formed of an electronic patch layer and a
disposable electrode layer. The disposable electrode layer has a
plurality of contact points for engagement with the surface of the
patient's body and is configured to measure short-lead ECG signals
in response to electrical activity in the heart. A processing unit
is provided and is configured to produce a transfer function which
computes estimated long-lead ECG signals based on the measured
short-lead ECG signals from the plurality of contact points.
[0104] In U.S. Pat. No. 6,441,747 to Khair et al., on Aug. 27, 2002
and U.S. Pat. No. 6,496,705 to Ng et al., on Dec. 17, 2002, there
are disclosed a wireless, programmable system for bio-potential
signal acquisition which includes a base unit and a plurality of
individual wireless, remotely programmable transceivers connected
to patch electrodes. The base unit manages the transceivers by
issuing registration, configuration, data acquisition, and
transmission commands using wireless techniques. The bio-potential
signals from the wireless transceivers are demultiplexed and
supplied via a standard interface to a conventional ECG monitor for
display.
[0105] U.S. Pat. No. 8,315,695 to Sebelius et al. on Nov. 12, 2012
and U.S. Pat. App. No. 2010/0234746 to Frederick Sebelius, disclose
a system for wireless generation of at least one standard ECG lead
comprises a plurality of electrodes for application to a subject at
separate points thereof and a remote receiver station for
generating at least one standard ECG lead from signals detected by
a first group of said plurality of electrodes. The system further
comprises a wireless sensing unit for generating at least two
non-standard ECG signals from bipolar signals detected by a second
group of the plurality of electrodes, a processor in the remote
receiver station for calculation of a transform synthesizing each
generated standard ECG lead from at least two of the non-standard
ECG signals, a disconnection unit for disconnection of the first
group of electrodes from the subject following the calculation, and
a transfer unit for wireless transferring of the non-standard ECG
signals to the remote receiver station following the disconnection
of the first group of electrodes.
[0106] U.S. Pat. No. 7,403,808 to Istvan et al. on Jul. 22, 2008,
discloses a cardiac monitoring system for detecting electrical
signals from a patient's heart and wirelessly transmit the signals
digitally to a remote base station via telemetry. The base station
converts the digital signals to analog signals which can be read by
an ECG monitor.
[0107] In U.S. Pat. No. 5,862,803 to Besson et al. on Jan. 26,
1999, U.S. Pat. No. 5,957,854 issued to Besson et al. on Sep. 28,
1999 and U.S. Pat. No. 6,289,238, also issued to Besson et al. on
Sep. 11, 2001, discloses a wireless medical diagnosis and
monitoring equipment which includes an evaluation station and a
plurality of electrodes which are arranged on a patient. Each of
the plurality of electrodes includes elementary sensors, sensor
control, transceivers, and transmission control units which are
integrated in one single semiconductor chip. The antenna that is
arranged in this connection in the flexible electrode covering or
directly in the chip.
[0108] In U.S. Pat. No. 4,981,141 to Jacob Segalowitz, on Jan. 1,
1991, there is disclosed an electrocardiographic monitoring system
in which the heart-signal sensing electrodes are each coupled to
the heart-signal monitor/recorder by respective wireless
transmitters and corresponding respective receiving wireless
receivers in a base unit.
[0109] U.S. Pat. No. 5,168,874 issued to Jacob Segalowitz, on Dec.
8, 1992, discloses a wireless electrode structure for use in
patient monitoring system. It is a two-sectioned system having a
plurality of micro-chipped, self-contained and self-powered heart
signal sensing, amplifying, encoding and R-F transmitting,
detecting electrodes and a receiving, demodulation and decoding
base unit capable of developing real-time, signal averaging
electrocardiography for a 12-lead ECG.
[0110] U.S. Pat. No. 5,307,818 issued to Jacob Segalowitz,
discloses a precordial strip assembly medical monitoring system for
use on a patient having skin, right and left arms and legs and a
heart with a precordium lying thereover comprising an elongated
strip having first and second surfaces.
[0111] U.S. App. No. 2014/0243694 to Baker et al, published Aug.
29, 2014 discloses a body-worn patient monitoring device which
provides a substrate that supports one or more electrical
connections to a patient's body. The method further includes
determining a print pattern and thickness of a first material
having a first resistivity to be printed on the substrate,
determining a print pattern and thickness of a second material
having a second resistivity to be printed on substrate, printing
the second material onto the substrate wherein at least part of the
second material overlays the first material.
[0112] U.S. App. No. 2014/0236249 to Rao et al., published Aug. 21,
2014 discloses a novel wearable electronic skin patch sensor device
configured for the real time acquisition, processing and
communicating cardiac activity and other types of biological
information within a wired or wireless network. A system level
scheme for networking the sensor device with client devices that
include intelligent personal health management appliances, cellular
telephones, PDAs, portable computers, RFID tags and servers is
disclosed.
[0113] U.S. Pat. No. 5,796,827 to Coppersmith et al., published
Aug. 18, 1998 discloses a system and method for near-field human
coupling for encrypted communication with identification cards. The
apparatus and method for encoding and transferring data from a
transmitter to a receiver, using the human body as a transmission
medium is disclosed.
[0114] U.S. Pat. No. 3,943,918, issued to Ronald A. Lewis, on Mar.
6, 1976 discloses disposable physiological telemetric device which
includes a one-time use self-powering battery means, adhesive
means, adhesive means for attachment of the device to the patient
and electrodes for sensing the physiological functioning. A
disposable cover is removed to expose the adhesive means and the
battery means are actuated to power the device at the time of use.
The radio frequency transmitter signal is received on suitable
radio telemetry for monitoring and recording as desired.
[0115] U.S. Pat. No. 6,132,371 issued to Dempsey, et al., on Oct.
17, 2000 discloses a leadless monitoring of physiological
conditions. The monitoring includes a transducer and a transponder.
The transducer is adapted to sense the physiological condition of
the patient and produce an output signal indicative of the sensed
condition. The transponder is arranged to receive an
electromagnetic signal and re-radiate the electromagnetic
signal.
[0116] U.S. Pat. No. 4,679,144 issued to Cox, et al., on Jul. 7,
1987 discloses an apparatus for monitoring EKG information includes
a programmable apparatus carried by an ambulatory patient for
performing continuous, real-time analyses of EKG information
derived from the patient. The apparatus facilitates the
determination of the existence of various conditions based on these
analyses which portend cardiac complications including myocardial
ischemia, and arrhythemia activity and further instructs the
patient on the manner of treatment required for the detected
condition.
[0117] U.S. Pat. No. 8,430,310 issued to Ho, et al., on Apr. 30,
2013, discloses a system, method and device for identifying a user
associated with a wearable electronic device. First, a directed
electromagnetic radiation comprising an identifier associated with
a user of the wearable electronic device is transmitted to a first
target device. In response, a challenge signal is received
requesting a verification response verifying the authenticity of
the identifier. The wearable electronic device than detects a
predefined user input, and responsive to receiving the challenge
signal and detecting the predefined user input, transmits a
challenge response corresponding to the predefined user input to a
second target device. The first and second target devices may be
the same device. The predefined user input may be comprise one or
more sensed head movements and/or detected user input
operations.
[0118] U.S. Pat. No. 8,482,487 issued to Rhodes, et al. on Jul. 9,
2013, discloses a method and device for displaying images. In some
example embodiments, methods may include receiving data
corresponding to an image. The image data may include at least one
image object. Each image object may be assigned to either a
foreground image set or a background image set. An embodiment may
also include rendering a first display image based on at least the
foreground image set. The first display image may include the
objects assigned to the foreground image set. Additionally, the
objects assigned to the foreground image set may be in focus in the
first display image. Embodiments may also include rendering a
second display image based on at least the background image set.
The second display image may include the objects assigned to the
background image set. Additionally, the objects assigned to the
background image set may be in focus in the second display
image.
[0119] U.S. Pat. Appl. No. 2014/0018635 to Buchheim et al.
discloses a signal processing apparatus for determining a heart
rate includes a plurality of sensors configured to detect changes
in blood properties in a user's skin and a heart rate Kalman filter
configured to compute a heart rate on the basis of signals obtained
from the plurality of sensors. A method of computing a heart rate
using the apparatus includes detecting changes in blood properties
with a plurality of sensors, and computing with a heart rate Kalman
filter the heart rate on the basis of signals obtained from the
plurality of sensors.
[0120] The monitoring device may be configured to include a means
for interacting with the user. The interaction can include a
vibration; a intermittent or periodic beacon signal broadcast to an
external device, flashing light emission, projection to an external
device though text, email or other communication application. The
interaction could also be via user interface. Such user interface
may stem from the capacitive touch user interface in DC-mode
configuration, in which the user interface may include an LCD
screen or OLED.
[0121] The monitoring device may communicate via a wired media such
as a wired network or direct-wired connection, and a wireless media
such as acoustic, RF, IR or other wireless media. A wired link may
include, for example, a parallel bus or a serial bus such as a
Universal Serial Bus (USB). The communication device may
communicate with a remote device via a connection. The connection
may be wired and/or a wireless link. A wireless link may include,
for example, Bluetooth, IEEE 802.11, Wi-Fi direct Cellular (such as
GSM, CDMA, UMTS, EV-DO, WiMAX, or LTE or GPS), or ZigBee, among
other possibilities. The connection between the monitoring device
may function to transmit data and/or commands to and/or from the
display device for transmission and/or reception by
transmission/reception devices and/or may function to transmit
display data for display on a display device such as but not
limited to a projector, tablet, mobile device, smartphone, personal
data assistant, a personal computer, a laptop computer, Google
glasses, wrist watch-type device, or even docking the monitoring
device on a communication device to download information or other
computing device. The connection may comprise one or more base
stations, routers, switches, LANs, WLANs, WANs, access points, or
other network infrastructures. For example, the monitoring device
may communicate with a cellular phone sending a text message
regarding an abnormal cardiac reading it received.
[0122] For secure transmission of a patient's information to a
communication device via a wireless link, the link may be secured
via any one of a plurality of available wireless security
protocols, including but not limited to, the Temporal Key Integrity
Protocol (TKIP), the Extensible Authentication Protocol (EAP), the
Lightweight Extensible Authentication Protocol (LEAP), the
Protected Extensible Authentication Protocol (PEAP), WiFi Protected
Access (WPA), the Advanced Encryption Standard (AES), and WLAN
Authentication and Privacy Infrastructure (WAPI).
[0123] The monitoring device may be a single device or two or more
components locking securely to provide accurate readings. Docking
the various components securely may occur using any of a plurality
of locking mechanisms, including but not limited to, Velcro,
screws, solder, sealants, fasteners, welding which may include
ultrasonic welding and magnets. For example, the monitoring device
may use asymmetrical magnetic contacts for firm attachment.
[0124] The device may be configured in various ways including but
not limited to circular, triangular, square, with wings, without
wings. The contacts may be any magnetic metals such gold, silver,
copper, iron or nickle. At least a portion of the enclosure may be
colored to match the skin tone of the patient, or contain a
decoration, art work, design, illustration or cartoon character to
provide a custom appearance to the device. It may be transparent or
at least partially translucent.
[0125] The wireless device may be positioned at various locations
throughout the body including but not limited to the chest,
shoulders, ribs, sides, back of shoulders and back. It can also be
externally attached to a belt, a wallet, in a pant pocket. The
monitoring device may be connected to a garment by attaching or
integrating one or more of the sensors into the garment.
Furthermore, the device may be made from at least one of, but not
limited to metal, silicone, liquid silicone rubber, silicone
eleastomers, metals, hard plastics, flexible polymers, glass,
polymethyl methcrylate (PMMA).
[0126] To comply with appropriate written description and
enablement requirements and to provide sufficient guidance in how
one of skill in the art can make and use the various embodiments of
the present invention, incorporated herein in their entireties are
the following: US Pat. Application Nos. 2014/0022163 to Olsson; and
2014/0066798 to Albert.
[0127] One or ordinary skill in the art will appreciate that
embodiments of the present invention may be constructed of
materials known to provide, or predictably manufactured to provide
the various aspects of the present invention.
[0128] This Summary of the Invention is neither intended nor should
it be construed as being representative of the full extent and
scope of the present invention. The present invention is set forth
in various levels of detail in the Summary of the Invention as well
as in the attached drawings and the Detailed Description, and no
limitation as to the scope of the present invention is intended by
either the inclusion or non-inclusion of elements, components, etc.
in this Summary of the Invention. Additional aspects of the present
invention will become more readily apparent from the Detailed
Description, particularly when taken together with the
drawings.
[0129] The preceding is a simplified summary of the disclosure to
provide an understanding of some aspects of the disclosure. This
summary is neither an extensive nor exhaustive overview of the
disclosure and its various aspects, embodiments, and/or
configurations. It is intended neither to identify key or critical
elements of the disclosure nor to delineate the scope of the
disclosure but to present selected concepts of the disclosure in a
simplified form as an introduction to the more detailed description
presented below. One of skill in the art will appreciate that the
entire disclosure, as well as the incorporated references,
pictures, etcetera will provide a basis for the scope of the
present invention as it may be claimed now and in future
applications.
BRIEF DESCRIPTION OF THE DRAWINGS
[0130] The accompanying drawings, which are incorporated in and
constitute a part of the specification, illustrate embodiments of
the invention and together with the general description of the
disclosure given above and the Detailed Description of the drawings
given below, serve to explain the principles of the disclosures.
The present disclosure is described in conjunction with the
appended figures, which are not necessarily drawn to scale.
[0131] FIG. 1 illustrates the use of a wired monitoring system on a
patient;
[0132] FIG. 2A illustrates a DC mode charging configuration;
[0133] FIG. 2B illustrates a DC mode charging configuration;
[0134] FIG. 3 illustrates a device with scroll wheel;
[0135] FIG. 4 illustrates the perimeter of the adhesive patch of a
monitoring device;
[0136] FIG. 5A illustrates a perspective view of a monitoring
device;
[0137] FIG. 5B illustrates a secondary perspective view of a
monitoring device;
[0138] FIG. 6 illustrates an electrode design for a monitoring
device;
[0139] FIG. 7 illustrates a transmit coil for inductive
coupling;
[0140] FIG. 8 illustrates an exemplary human body of
capacitance
[0141] FIG. 9 illustrates a communication system using an epidermal
bus;
[0142] FIG. 10 illustrates a modulation/demodulation system;
[0143] FIG. 11 illustrates coupling as it occurs on the ECN;
[0144] FIG. 12 illustrates an ECN enabled module;
[0145] FIG. 13 is a flowchart illustrating ECN communication.
DETAILED DESCRIPTION
[0146] In the following detailed description, numerous specific
details are set forth in order to provide a thorough understanding
of the disclosed techniques. However, it will be understood by
those skilled in the art that the present embodiments may be
practiced without these specific details. In other instances,
well-known methods, procedures, components and circuits have not
been described in detail so as not to obscure the present
disclosure.
[0147] Although embodiments are not limited in this regard,
discussions utilizing terms such as, for example, "processing,"
"computing," "calculating," "determining," "establishing",
"analyzing", "checking", or the like, may refer to operation(s)
and/or process(es) of a computer, a computing platform, a computing
system, a communication system or subsystem, or other electronic
computing device, that manipulate and/or transform data represented
as physical (e.g., electronic) quantities within the computer's
registers and/or memories into other data similarly represented as
physical quantities within the computer's registers and/or memories
or other information storage medium that may store instructions to
perform operations and/or processes.
[0148] Although embodiments are not limited in this regard, the
terms "plurality" and "a plurality" as used herein may include, for
example, "multiple" or "two or more". The terms "plurality" or "a
plurality" may be used throughout the specification to describe two
or more components, devices, elements, units, parameters, circuits,
or the like.
[0149] Before undertaking the description of embodiments below, it
may be advantageous to set forth definitions of certain words and
phrases used throughout this document: the terms "include" and
"comprise," as well as derivatives thereof, mean inclusion without
limitation; the term "or," is inclusive, meaning and/or; the
phrases "associated with" and "associated therewith," as well as
derivatives thereof, may mean to include, be included within,
interconnect with, interconnected with, contain, be contained
within, connect to or with, couple to or with, be communicable
with, cooperate with, interleave, juxtapose, be proximate to, be
bound to or with, have, or the like; and the term "controller"
means any device, system or part thereof that controls at least one
operation, such a device may be implemented in hardware, circuitry,
firmware or software, or combination of at least two of the same.
It should be noted that the functionality associated with any
particular controller may be centralized or distributed, whether
locally or remotely. Definitions for certain words and phrases are
provided throughout this document and those of ordinary skill in
the art should understand that in many, if not most instances, such
definitions apply to prior, as well as future uses of such defined
words and phrases.
[0150] The exemplary embodiments will be described in relation to
communications systems, as well as protocols, techniques, means and
methods for performing communications, such as in an epidermal
communication network, or in general in any communications network
operating using any communications protocol(s) including the body
area network. It should be appreciated however that in general, the
systems, methods and techniques disclosed herein will work equally
well for other types of communications environments, networks
and/or protocols.
[0151] For purposes of explanation, numerous details are set forth
in order to provide a thorough understanding of the present
techniques. It should be appreciated however that the present
disclosure may be practiced in a variety of ways beyond the
specific details set forth herein. Furthermore, while the exemplary
embodiments illustrated herein show various components of the
system collocated, it is to be appreciated that the various
components of the system can be located at distant portions of a
distributed network, such as a communications network, node, and/or
the Internet, or within a dedicated secured, unsecured, and/or
encrypted system and/or within a network operation or management
device that is located inside or outside the network. As an
example, a wireless device can also be used to refer to any device,
system or module that manages and/or configures or communicates
with any one or more aspects of the network or communications
environment and/or transceiver(s) and/or stations and/or access
point(s) described herein.
[0152] Thus, it should be appreciated that the components of the
system can be combined into one or more devices, or split between
devices, such as a transceiver, an access point, a station, a
network operation or management device, a node or collocated on a
particular node of a distributed network, such as a communications
network and can be docketed onto a system on a chip, system on a
module and the like for communicating over the body network. As
will be appreciated from the following description, and for reasons
of computational efficiency, the components of the system can be
arranged at any location within a user and/or network without
affecting the operation thereof.
[0153] Furthermore, it should be appreciated that the various
links, including the communications channel(s) connecting the
elements can be wired or wireless links or any combination thereof,
or any other known or later developed element(s) capable of
supplying and/or communicating data to and from the connected
elements. The term module as used herein can refer to any known or
later developed hardware, circuitry, software, firmware, or
combination thereof, that is capable of performing the
functionality associated with that element. The terms determine,
calculate, and compute and variations thereof, as used herein are
used interchangeably and include any type of methodology, process,
technique, mathematical operational or protocol.
[0154] Moreover, while some of the exemplary embodiments described
herein are directed toward a transmitter portion of a transceiver
performing certain functions, this disclosure is intended to
include corresponding and complementary receiver-side functionality
in both the same transceiver and/or another transceiver(s), and
vice versa.
[0155] Embodiments provide novel networking mechanisms that
facilitate patient monitoring while using a wireless monitoring
device. A means for communicating with the wireless monitoring
device can include an ECN and/or other body area networks and can
be adapted to communicate with the ECN and other external devices
via an ECN enabled module. The use of the ECN can provide efficient
communication using analog processing for low power, low frequency
and low computational costs. Other advantages exist as well as will
be discussed herein.
[0156] The invention describes herein relates to a wireless ECG.
The invention solution presents a safe, intuitive means for making
ECG measurements without the use of wires. It provides an ECG
measurement system with a higher degree of comfort and easier
management for the practitioner. Further, the invention introduces
a two charging schemes that are intrinsically safe and reliable.
Still furthermore, the invention describes a way of synchronizing
the sensors on the monitoring device by way of a master/slave
synchronization method in order to provide reliable measurements.
Having described the invention, alternatives and embodiments may
occur to one of skill in the art.
[0157] FIG. 1 illustrates the use of a wired monitoring system 100
on a patient. As illustrated in FIG. 1, the perspective view of the
wired monitoring system 100 can include the use of an ECG monitor
device with wired leads. FIG. 1 is incorporated herein in its
entirety from U.S. Pub. Appl. No. 2010/0234746 to Frederick
Sebelius. Figure illustrates, for example, how the wired monitoring
system can be connected to a user. As apparent from FIG. 1, a wired
monitoring system can be quiet cumbersome to operate. For example,
the wires can be tugged, disconnected and set off lead-off alarms,
the lead connections can be incorrectly situated leading to an
incorrect reading, or the connections can be exposed to RF
interference. Even further, a user has an increased probability of
infection due to bodily fluid exposure by the wires.
[0158] A wireless monitoring device can overcome these
deficiencies. For example, a user can be provided with a simple yet
intuitive device that adheres to the user to enable a less
cumbersome means for monitoring. The device can be a wireless ECG
monitor, for example, that provides access to data logs, monitors
the user, and even includes a safe intrinsic method for charging.
The charging can occur via a device enclosure as illustrated in
FIGS. 2A and 2B. FIGS. 2A and 2B illustrate DC mode configurations.
FIG. 2A displays a perspective view of a device enclosure 200
configured for DC charging. The device enclosure 200 includes a top
charging sleeve 202 and a bottom docking sleeve 208. For intrinsic
safety and for proper alignment, the enclosures top and bottom
sleeves 202,208 can include magnetic polarities that provide an
asymmetrical configuration for safe charging. The magnetic
polarities can include anodes and cathodes 204a-204g. In one
example, 204a and 204e can be the cathodes, while 204b-d and 204f-g
are anodes. The top charging sleeve 202 can be equipped with
matching counterparts that are identically asymmetrical to the
bottom docking sleeve 208. By creating a monitoring device with
magnetic polarities, a limited number of permutations fits are
available, this provides a guide for correct docking of the
charging device enclosure 200. The strong magnetic force exerted by
the anodes and cathodes, 204a-204g, ensures a strong interaction
between the top charging sleeve 202 and the bottom docking sleeve
208, which can be easily attached and/or removed. In addition, by
providing this symmetric configuration, the enclosure between the
bottom docking sleeve 208 and the top charging sleeve ensure that
the magnetic fields will not impact the integrity of the signal. In
another example, 204a and 204e can be anodes, and 204b-d and 204f-g
are cathodes. The configuration of the anodes and cathodes,
204a-204g can be arranged in any configuration such that a
symmetric configuration is achieved for safe intrinsic charging.
Alternatively, the anodes and cathodes, 204a-204g can be arranged
in an asymmetric configuration.
[0159] In addition, the battery and charging circuitry can be
embedded within the charging sleeve 202. FIG. 2B shows a
perspective view of the charging implementation. In FIG. 2B, the
top charging sleeve 202 is presented with at least one
configuration of the circuitry. The anodes and cathodes 204a-204d
can be configured to connect to clocks, buses and other system
protocols. In one example, anodes and cathodes 204a and 204d can be
assigned to the SMCLK 224 and SMDATA 232 clock roles, respectively
from the System Management Bus Protocol and anodes and cathodes
204b and 204c can be assigned to r 220 and/or V.sup.- 228. The
incorporation of communication protocols between charger and module
(and interoperability with other common protocols such as I2C)
allows for simple integration with a host processor. Components,
including, but not limited to LEDs, piezos, GUIs, etc., can be used
to indicate charging. The magnetic components can be conductive
metals including, but not limited to gold, silver, aluminum, zinc,
nickel, brass, bronze, iron, platinum, steel, lead, etc., and can
be non-corrosive.
[0160] Smart detection technology can be incorporated into the
monitoring device to ensure effective charging and in instances
where most appropriate for the user. For example, the device can be
activated for charging when attached, and verified by a hand-shake
between the charger and a host system. The communication between
the charger and host system can occur through a bus and only if
charging unit is properly detected.
[0161] The monitoring device can therefore present multi-user
interface functions and locking mechanisms. For example, the
monitoring device 300 can include a scroll wheel 304, as
illustrated on FIG. 3. The scroll can provide a safe means for
locking the device, avoiding accidental triggers. The scroll wheel
304 can further be used to retrieve a user's information by means
of the scroll wheel 304. The magnetic contacts, as described above
and in conjunction with FIG. 2, can preferably serve as a
multi-input capacitive touch user-interface and even more
preferably the magnetic contacts are positioned at various
locations as the wheel is adjusted, providing for varying services
including but not limited to patient's records, ECG data and other
menu items. The scroll wheel 304 can for example, work similar to
that of a pattern-lock on a smartphone. That is to say, the scroll
wheel 304 can rotate in a series of directions (i.e. 2 turns
clockwise, 1 counterclockwise) to enable user input. In many
embodiments of the present invention, the number of contacts vary,
increasing the number of patters that may be added. In one
embodiment, the user input screen may be configured to time-out
after non-use for a predetermined number of minutes. In another
embodiment, a 1/2 turn in the clockwise direction can retrieve user
data. In another embodiment, rotation in the counter-clockwise
direction can retrieve or permit one or more functions. The number
of rotations, combination of rotations and direction of rotation is
not limited and can include one or more configurations. In addition
to the scroll wheel 304, the monitoring device 300 on FIG. 3, can
also include capacitive touch inputs 312 and organic light emitting
diode (OLED) 308 for user interaction. Alternatively or
additionally, the monitoring device 300 can include an LCD (not
shown) screen for at least user interaction, data retrieval, and
user monitoring. The capacitive touch device can be directed to the
use of the interactive scheme in which the monitoring device may be
wirelessly controlled by a peripheral communication device. Such
communication device may include but not limited to a laptop,
tablet, smartphone, etc. Such external connectivity provides
further control and customization the device. Therefore, the user
can now have access to dynamic switching, zooming and programming
(i.e. entering user data, network info, selecting menu options,
etc.)
[0162] FIG. 4 illustrates the perimeter of the adhesive patch of a
monitoring device. FIG. 4 further provides a schematic that is an
exemplary extension to the device configuration used in FIGS.
2A-2B, wherein four contacts 212 where used. The arrangement of the
contacts, are not limited to 4 and/or placement of the contacts can
be arranged in a circular, triangular, rectangular, polygonal,
mesh, hexagonal, star, diamond or any other arrangement including
preferably in a parallel manner. The number of contacts may be any
number greater than two. For example, n conductive elements may be
arranged around the circumference of the device as illustrated in
FIG. 4.
[0163] In this embodiment, the monitoring device 400 can be
configured n-pairs of electrodes 304 organized concentrically
around the perimeter of the adhesive patch. The placement creates a
thin film, flexible electrode angular array. This arrangement
allows selection of any pair of electrodes 404 at any given time.
The electrodes can be used for example, but not limited to
capacitive charging 412, in conjunction with a system management
bus protocol 416, for general ECG measurement 420, as a multi-input
capacitive user-interface 424, and for communication with an ECN
enabled module 428. In addition, this configuration provides
simplicity and is useful as ultra-low power. The thin film array
placement can be plated directly onto a PCB board and/or the
spacing between consists of an insulator block 324.
[0164] FIGS. 5A-5B illustrate perspective views of the monitoring
device 500, 550. Although only examples of a possible design, FIGS.
5A and 5B provide varying view. FIG. 5A illustrates the front-side
view 500 of the device with four contacts 504a-d, and at least an
LCD 508 and/or OLED (not shown). FIG. 5B illustrates the back-side
view 550 of the monitoring device. The magnetic contacts 504a-504g
can be gold plated for efficient charge transfer and to prevent
possible corrosion caused by environmental factors.
[0165] FIG. 6 illustrates a contacts design for a monitoring
device. FIG. 6 further illustrates that contacts/electrodes
604a-604f can be designed to provide greater signal amplitude by
increasing the space between the diametrically opposed pairs of
contacts/electrodes 604a-604f. As the distance 608 between the
contacts increases, the greater the signal. In one example, the
distance between contacts 604a and 604d is increased. In another
example, the distance between contacts 604b and 604 e is increased.
Still in another example, the distance between contacts 604c and
604d is increase. The distances 608 between the contacts can be
increased between any two or more contacts. The distance 608
between two contacts can be different than the distance between any
other two contacts. The distance between two or more contacts can
be the same. The distance between any two contacts can be different
for each contact.
[0166] In addition, to the use of the four contacts for charging as
described above and in conjunction with FIGS. 2A and 2B, FIG. 7
illustrates a transmit coil 700 for inductive charging. By using a
magnetic ring/transmit coil 700 along both the perimeter of both
the top and bottom of the monitoring device with the multiple
contacts, secure coupling can achieved. In one example, the top
side of the monitoring device can be disposable. In another
example, the bottom side of the monitoring device is disposable.
Still in another example, the disposable side can be employed by
magnets. Still yet in another example, coupling can be achieved
using a material with a highly magnetic permeability such as, but
not limited to an un-magnetized iron. The transmit coil 700 can be
slipped over the device enclosure (i.e. top charging sleeve and/or
the bottom docking sleeve) integrated into the monitoring device.
In one example, the magnetic contacts (i.e. cathodes and anodes)
can still be present, however charging does not take place across
them. In another example, the magnetic contacts are present and
charging occurs across the magnetic contacts and on the transmit
coil 700. The use of transmit coil 700 can produce an alternating
current which is passed through the top charging sleeve. The
current can be inductively coupled onto a second coil/receive coil
(similar to transmit coil 700) where it can be rectified and
conditioned to charge a smaller capacity on-board battery.
Modulation can be applied to the inductive coupling to the
inductive charging current to transmit information between the
monitoring device and the charging unit.
[0167] Information can also occur between the monitoring device and
other devices located on the body and/or external to the body. For
example, the monitoring device can communicate with a wearable
device, such as a band, clock, glasses, etc. In one example, the
communication can occur on the body, via the use of an epidermal
communication network (ECN). Communication can occur over an
epidermal communication network because the human body can be
modeled as an RC network. FIG. 8 illustrates an exemplary model of
a Human Body Model of Capacitance 800. Since body resistance and
capacitance are both physical properties of the human body, the
human body/user 804 can be modeled as a simple RC low-pass filter
network 806. The RC low-pass filter 806 illustrated in FIG. 8 can
include a resistor 808 and a capacitor 812 connected in series and
a ground 816. The input point 820 and/or output point 824 can be an
output point anywhere on the epidermis of a user 804. A voltage can
be transmitted from the user 804 to point 824, where point 824
outputs a proportional, attenuated voltage to that applied at point
the input of the user 804.
[0168] FIG. 9 illustrates a communication system using an epidermal
bus. That is, the communication system of FIG. 9 illustrates the
use of the human body as an epidermal bus 912 for communication
between two devices. The data can be transmitted and/or received at
ECN transceivers 908, 916 via the epidermal bus 912 and/or from
standard data buses 904 and 920. The ECN transceivers 908, 916 can
be any type of communication device including wearable devices such
as but not limited to ECG monitors, watches, bracelets, necklaces,
bands, body bands, glasses, jewelry, fabric, cellular phones, smart
phones, iPads, smart pads, laptops, PDAs, etc. The ECN
transceivers, can further include communication devices that are
ECN enabled to provide wireless communication between each other,
between wired devices, between external devices (i.e.,
Bluetooth.RTM., NFC, WiDi, WLAN communications, etc.) and any other
type of communication system. The ECN transceivers 908 and 916 if
not ECN enabled, can include an ECN interface to transfer, upload,
and/or download information between devices with the epidermal bus
912. The ECN transceivers 908 and 916 can further include all the
major components for signal processing including
modulation/demodulation, arbitration, signal conditioning,
identification and encryption/decryption. Further details regarding
the basic components in the ECN transceiver 908, 916 will be
discussed below and in conjunction with FIG. 10 and FIG. 12.
[0169] FIG. 10 illustrates a basic modulation/demodulation system
1000. The modulations/demodulation system 1000 from FIG. 10
provides exemplary components used in conjunction with the
modulation process used in ECN communications. The basic
modulation/demodulation system 1000 can include mixers 1004,
filters 1008, 1016, phase comparators 1012, oscillators 1020,
samplers 1024, summers 1028, etc. The filters can include tunable
band pass filters, low pass filters, notch filters, digital
filters, IIRs, FIRs, passive filters, active filters, analog
filters, digital filters, etc. The modulation/demodulation scheme
for use with communications over the ECN network can include On-Off
Keying modulation. On-Off Modulation is a simple form of
Amplitude-Shift Keying modulation which provides for a more
spectral efficient modulation than FSK modulation. Other
modulation/demodulation schemes can be used for communication over
an ECN network as well. For example, the modulation schemes can
include Amplitude Modulation, Frequency Modulation, Phase
Modulation, Quadrature Amplitude Modulation, Space Modulation,
Single-Sideband Modulation, Amplitude Shift Keying, Frequency Shift
Keying (FSK), Phase Shift Keying (PSK), Quadrature Phase Shift
Keying (QPSK), Spread Spectrum, Orthogonal Frequency-Division
Multiplexing (OFDM), OFDMA, etc.
[0170] For the communication to occur over the ECN network,
coupling as illustrated in coupling diagram 1100 on FIG. 11 occurs.
Coupling is the transfer of energy within a network by means a
capacitance between two nodes and is often known as capacitive
coupling. In some instances stray or parasitic coupling occurs in
which unavoidable capacitance or energy transfer occurs due to the
proximity of components. FIG. 11 illustrates the coupling diagram
where a transmitter module 1102 and a receiver module 1104 are
communicating over an ECN network. In the communication between the
devices, a signal input/output 1120, 1128 and ground 1124, 1132
will at least exist at each transmit and receive module 1102, 1004.
In communicating over the ECN, a signal departing from the signal
output of the transmit module 1102 can take one of two routes, the
signal can couple C2 1112 the receive ground 1132 and/or can couple
C1 1108 to the signal in 1128. Alternatively or additionally, the
transmit module 1102 can include a ground 1124 which couples C3
1116 to the receiver module 1104 via a ground 1132. In one example,
the coupling C2 1112 that occurs between the ground 1124 of the
transmit module 1102 and the ground 1132 of the receive module 1104
occurs through air. In addition, the coupling C1 1108 between the
signal out 1120 and the signal in 1128 occurs through the skin of a
user. Therefore, coupling C2 1112 takes the form of parasitic
coupling. When this occurs, the path of the coupling C1 1108 is
stronger that of the coupling C2 1112 and the signal is transmitted
over the ECN network. Thus, the dielectric properties of the human
body or a user create a better capacitor for coupling C1 1108 than
free air without the need for an earth ground at a low voltage.
C.sub.body>C.sub.air
[0171] In some instances, to increase the coupling between the
signal out 1120 and the signal in 1128, i.e., to increase coupling
C1 1109, bandages, lotions, lubricants, etc., can be added. For
example, an adhesive patch can include micro-spikes which aid in
the coupling and signal transfer between the monitoring device
and/or another wearable device, a wired device, a wireless device
and other devices of the like. The microspikes can include an
adhesive bandage, patch other similar material on the monitoring
device or on as a separate mechanism that includes miniature
speared objects that can minimally penetrate the skin to a more
conductive layer for better user coupling and signal transmission.
Alternatively or in addition, a body lotion, lubricant, or other
viscous substance can be applied on the epidermis of the user to
increase the conductivity for better signal transmission.
[0172] In another example, galvanic coupling can occur between the
transmit module 1102 and the receive module 1104 which enables body
network communications or the communication over an epidermal
communication network (ECN). In galvanic coupling, the signal will
travel and energy will transfer between nodes (i.e. ground 1132,
signal in 1128, etc.) and across various parts of the human
body/user, with coupling occurring at the signal in 1128 where the
wearable device or monitoring device may be. In yet another
example, earth ground coupling occurs and the signal is transferred
through the epidermis. The use of galvanic coupling for intra-body
communications further described in "An Efficient Pulse Position
Modulation Transmitter for Galvanic Intrabody Communications" to
MirJojjat Seyedi and is incorporated herein in its entirety.
Personal area networks (PAN) are used in the signal transmission
and explained through galvanic coupling. PAN is explained in
further detail in both "Personal Area Networks (PAN): Near-field
intra-body communications." M. S. thesis to T. G. Zimmerman, and
U.S. Pat. No. 5,914,701 to Gersheneld et. al. and are incorporated
herein in their entirety. Additional coupling details are also
found in "Body-Coupled Communications--Experimental
characterization, channel modeling and physical layer design," M.
S. thesis to N. S. Mazloum and is incorporated herein in its
entirety. Furthermore, in some instances where galvanic coupling is
used through body data transfer occurs. In other instances, where
parasitic coupling is used, through body data transfer also occurs.
U. S. Publication No. 2013/0142363, "Devices and Methods for
Transferring Data Through A Human Body" to B. Amento details a
method for transferring data to a device though a user and is
incorporated herein in its entirety. Still further, in some
instances, implantable Intra-Body communication can be used in
conjunction with galvanic coupling. As appreciated in view of the
guidance provided herein, including a more detailed description as
described "Development and Prospect of Implantable Intra-Body
Communication Technology" by S. Zhang, is further incorporated by
reference herein, various combinations of intra-body communication
is within the scope of the present invention.
[0173] FIG. 12 illustrates an ECN enabled module 1200. The ECN
enable module 1200 is a module that can work as an interface for
ECN communications in instances or in conjunction to wearable
and/or non-wearable devices that are ECN enabled. The ECN enabled
module 1200 is a module that can be used to docket or connect a
wearable device, wired, or wireless device for communication. The
ECN enabled module 1200 can work as a System on a Module (SOM).
Alternatively, the ECN enabled module 1200 can be a stand-alone
module that can reside on the same chip as a system on a chip
(SOC). In addition, the ECN enable module 1200 can further include
wearable electrode chips, stand-alone chips, and other chips on
modules which enable access to ECN. External systems to connect to
can include master/slave modules, modules whose internal operation
is abstracted and/or other such system which can be docketed onto
an ECN interface such as the ECN enable module 1200, for signal
transmission using the ECN.
[0174] The architecture of the ECN enabled module can closely
resemble a communication device with various output ports (i.e.,
1208, 1228, 1248, 1224, 1244, 1260) for docking and/or connectivity
with other components. As a System on a Module (SOM), the ECN
enable module 1200 can include one or more antennae 1204 for signal
transmission and reception. The antennae can provide for
Single-Input Single-Output (SISO) communications, Single-Input
Multi-Output (SIMO) communications, Multi-Input Single-Output
(MISO) and Multi-Input Multi-Output (MIMO) communications.
Additionally or alternatively, the antennae can be used in
Bluetooth.RTM., NFC, IR, etc., communications. The antennae can
include, but are not limited to dipoles, microstrip, monopoles,
slot, bow-tie, folded, loop, yagi-ura antennae.
[0175] The ECN enabled module 1200 can also include a network
access unit 1252 and MAC Circuitry 1212 for signal transmission and
contention. A transceiver 1220 is included in the ECN enabled
module 1200 for signal processing. In some instances, the signal
processing can occur before the ADC for lower consumption and
signal transmission at a lower frequency and savings in clock
cycles (i.e. the front-end is analog). Power consumption can be
minimized through the processing of the signal in the analog domain
enabling processing without the need for costly clock cycles and
processing in the digital domain. The signal processing both analog
and/or digital can occur in the controller/micro-processor 1256.
The transceiver can operate at frequencies as low as 500 KHz which
can include ping frequencies at +/-10 KHz (i.e., 510 KHz and 490
KHz). Further details regarding the transceiver (i.e. or
independently transmit and receive modules) are described above and
in conjunction with FIGS. 8 and 9.
[0176] Processing, data retrieval and/or data storage,
Memory/Storage module 1236 can be included in the architecture of
the ECN enabled module 1200. The Memory/Storage 1236 module can
include but is not limited to SDRAM, ROM, RAM, memory arrays, and
NVRAM. The Memory/Storage module 1236 can work in conjunction with
an ECN module 1232, which can work as an application for allowing
the connectivity between the various communication devices and the
ECN. The ECN module 1232 can further include instructions for
allowing signal transmission and processing. Further, the ECN
module 1232 can include rules and lookup tables for correct device
matching and configuration.
[0177] For secure transmission between the wearable devices, wired
and wireless devices, a security module 1216 can provide
appropriate keys such as, WEP and WAP. Signal encryption can also
occur in the security module 1216 and/or controller/micro-processor
1256 and/or transceiver 1220. Like the monitoring device described
above, the SOM ECN enabled module 1200 can include a display 1240
for user interaction if applicable. The ECN enabled module 1200 can
also include a photoplethysmographic sensor (not shown) for
monitoring health/fitness including heart rate logs. In addition,
as previously discussed, multiple-interfaces are available for data
transmission and reception between the communication devices. The
interfaces can include at least a UART 1208, I2C 1228, SDI2 1224,
SPI 1244, USB 1260 and others of the like in the I/O module
1248.
[0178] FIG. 13 is a flow chart illustrating exemplary signal
detection over an ECN network. In particular, the association
begins in step 1302 and continues to step 1304, where signal
detection occurs by an ECN enabled module. At this stage, the ECN
enabled module will receive the signal at step 1308 and determine
if the signal received arrived from a device that was ECN enabled
in step 1312. If the signal was transmitted by an ECN enabled
device, the device used and ECN interface, or the signal was
arrived in its appropriate format, then the signal is transferred
for processing at step 1320. Alternatively, if the signal was not
in an appropriate format, then the signal can be transferred to an
ECN module or application for signal treatment for appropriate
processing and transmission over the ECN network. Once the signal
is treated at step 1316, the signal is ready for processing at step
1320. After processing, the process ends at step 1324.
[0179] The exemplary systems and methods are described in relation
to a wireless health monitoring device enabled to operate on an ECN
and associated communication hardware, software and communication
channels. However, to avoid unnecessarily obscuring the present
disclosure, the following description omits well-known structures
and devices that may be shown in block diagram form or otherwise
summarized.
[0180] For purposes of explanation, numerous details are set forth
in order to provide a thorough understanding of the present
embodiments. It should be appreciated however, that the techniques
herein may be practiced in a variety of ways beyond the specific
details set forth herein.
[0181] Furthermore, it should be appreciated that the various
links, including communications channel(s), connecting the elements
(which may not be not shown) can be wired or wireless links, or any
combination thereof, or any other known or later developed
element(s) that is capable of supplying and/or communicating data
and/or signals to and from the connected elements and/or epidermal
communication networks and/or body area networks. The term module
as used herein can refer to any known or later developed hardware,
software, firmware, or combination thereof that is capable of
performing the functionality associated with that element. The
terms determine, calculate and compute, and variations thereof, as
used herein are used interchangeably and include any type of
methodology, process, mathematical operation or technique.
[0182] While the above-described flowcharts have been discussed in
relation to a particular sequence of events, it should be
appreciated that changes to this sequence can occur without
materially effecting the operation of the embodiment(s).
Additionally, the exact sequence of events need not occur as set
forth in the exemplary embodiments, but rather the steps can be
performed by one or the other transceiver in the communication
system provided both transceivers are aware of the technique being
used for initialization. Additionally, the exemplary techniques
illustrated herein are not limited to the specifically illustrated
embodiments but can also be utilized with the other exemplary
embodiments and each described feature is individually and
separately claimable.
[0183] The above-described system can be implemented on a wireless
telecommunications device(s)/system, such an 802.11 transceiver, or
the like. Examples of wireless protocols that can be used with this
technology include 802.11a, 802.11b, 802.11g, 802.11n, 802.11 ac,
802.11 ad, 802.11af, 802.11ah, 802.11ai, 802.11aj, 802.11aq,
802.11ax, 802.11u, WiFi, LTE, LTE Unlicensed, 4G, Bluetooth.RTM.,
WirelessHD, WiGig, 3GPP, Wireless LAN, WiMAX, PAN.
[0184] The term transceiver as used herein can refer to any device
that comprises hardware, software, firmware, or combination thereof
and is capable of performing any of the methods described
herein.
[0185] Additionally, the systems, methods and protocols can be
implemented on one or more of a special purpose computer, a
programmed microprocessor or microcontroller and peripheral
integrated circuit element(s), an ASIC or other integrated circuit,
a digital signal processor, a hard-wired electronic or logic
circuit such as discrete element circuit, a programmable logic
device such as PLD, PLA, FPGA, PAL, a modem, a
transmitter/receiver, any comparable means, or the like. In
general, any device capable of implementing a state machine that is
in turn capable of implementing the methodology illustrated herein
can be used to implement the various communication methods,
protocols and techniques according to the disclosure provided
herein.
[0186] Examples of the processors as described herein may include,
but are not limited to, at least one of Qualcomm.RTM.
Snapdragon.RTM. 800 and 801, Qualcomm.RTM. Snapdragon.RTM. 610 and
615 with 4G LTE Integration and 64-bit computing, Apple.RTM. A7
processor with 64-bit architecture, Apple.RTM. M7 motion
coprocessors, Samsung.RTM. Exynos.RTM. series, the Intel.RTM.
Core.TM. family of processors, the Intel.RTM. Xeon.RTM. family of
processors, the Intel.RTM. Atom.TM. family of processors, the Intel
Itanium.RTM. family of processors, Intel.RTM. Core.RTM. i5-4670K
and i7-4770K 22 nm Haswell, Intel.RTM. Core.RTM. i5-3570K 22 nm Ivy
Bridge, the AMD.RTM. FX.TM. family of processors, AMD.RTM. FX-4300,
FX-6300, and FX-8350 32 nm Vishera, AMD.RTM. Kaveri processors,
Texas Instruments.RTM. Jacinto C6000.TM. automotive infotainment
processors, Texas Instruments.RTM. OMAP.TM. automotive-grade mobile
processors, ARM.RTM. Cortex.TM.-M processors, ARM.RTM. Cortex-A and
ARM926EJ-S.TM. processors, Broadcom.RTM. AirForce BCM4704/BCM4703
wireless networking processors, the AR7100 Wireless Network
Processing Unit, other industry-equivalent processors, and may
perform computational functions using any known or future-developed
standard, instruction set, libraries, and/or architecture.
[0187] Furthermore, the disclosed methods may be readily
implemented in software using object or object-oriented software
development environments that provide portable source code that can
be used on a variety of computer or workstation platforms.
Alternatively, the disclosed system may be implemented partially or
fully in hardware using standard logic circuits or VLSI design.
Whether software or hardware is used to implement the systems in
accordance with the embodiments is dependent on the speed and/or
efficiency requirements of the system, the particular function, and
the particular software or hardware systems or microprocessor or
microcomputer systems being utilized. The communication systems,
methods and protocols illustrated herein can be readily implemented
in hardware and/or software using any known or later developed
systems or structures, devices and/or software by those of ordinary
skill in the applicable art from the functional description
provided herein and with a general basic knowledge of the computer
and telecommunications arts.
[0188] Moreover, the disclosed methods may be readily implemented
in software and/or firmware that can be stored on a storage medium,
executed on programmed general-purpose computer with the
cooperation of a controller and memory, a special purpose computer,
a microprocessor, or the like. In these instances, the systems and
methods can be implemented as program embedded on personal computer
such as an applet, JAVA.RTM. or CGI script, as a resource residing
on a server or computer workstation, as a routine embedded in a
dedicated communication system or system component, or the like.
The system can also be implemented by physically incorporating the
system and/or method into a software and/or hardware system, such
as the hardware and software systems of a communications
transceiver.
[0189] It is therefore apparent that there has been provided
systems and methods for ECG monitoring, the use of an ECN network,
and an ECN enabled module for communication over and interfacing
with the ECN. While the embodiments have been described in
conjunction with a number of embodiments, it is evident that many
alternatives, modifications and variations would be or are apparent
to those of ordinary skill in the applicable arts. Accordingly, it
is intended to embrace all such alternatives, modifications,
equivalents and variations that are within the spirit and scope of
this disclosure.
[0190] The present disclosure, in various aspects, embodiments,
and/or configurations, includes components, methods, processes,
systems and/or apparatus substantially as depicted and described
herein, including various aspects, embodiments, configurations
embodiments, sub-combinations, and/or subsets thereof. Those of
skill in the art will understand how to make and use the disclosed
aspects, embodiments, and/or configurations after understanding the
present disclosure. The present disclosure, in various aspects,
embodiments, and/or configurations, includes providing devices and
processes in the absence of items not depicted and/or described
herein or in various aspects, embodiments, and/or configurations
hereof, including in the absence of such items as may have been
used in previous devices or processes, e.g., for improving
performance, achieving ease and/or reducing cost of
implementation.
[0191] The foregoing discussion has been presented for purposes of
illustration and description. The foregoing is not intended to
limit the disclosure to the form or forms disclosed herein. In the
foregoing Detailed Description for example, various features of the
disclosure are grouped together in one or more aspects,
embodiments, and/or configurations for the purpose of streamlining
the disclosure. The features of the aspects, embodiments, and/or
configurations of the disclosure may be combined in alternate
aspects, embodiments, and/or configurations other than those
discussed above. This method of disclosure is not to be interpreted
as reflecting an intention that the claims require more features
than are expressly recited in each claim. Rather, as the following
claims reflect, inventive aspects lie in less than all features of
a single foregoing disclosed aspect, embodiment, and/or
configuration. Thus, the following claims are hereby incorporated
into this Detailed Description, with each claim standing on its own
as a separate preferred embodiment of the disclosure.
* * * * *