U.S. patent application number 15/374393 was filed with the patent office on 2017-06-01 for wearable fetal monitoring system having textile electrodes.
This patent application is currently assigned to HEALTHWATCH LTD.. The applicant listed for this patent is HEALTHWATCH LTD.. Invention is credited to Uri AMIR, Itzhak Katz, Oleg Malafriev.
Application Number | 20170150926 15/374393 |
Document ID | / |
Family ID | 51988114 |
Filed Date | 2017-06-01 |
United States Patent
Application |
20170150926 |
Kind Code |
A1 |
AMIR; Uri ; et al. |
June 1, 2017 |
WEARABLE FETAL MONITORING SYSTEM HAVING TEXTILE ELECTRODES
Abstract
A seamless, smart fetal monitoring garment and methods of using
thereof. The system includes a knitted or interwoven garment having
a multiplicity of conductive textile electrodes for sensing
maternal and fetal electrical vital signals. The maternal and fetal
electrical vital signals are selected from a group including
maternal heart rate, fetal heart rate and electromyogram (EMG)
activities including uterine activities. The method includes
wearing the garment, acquiring electrical mixed common, maternal
and fetal vital signals from surface region of a pregnant woman,
using the plurality of textile electrodes, optimally weighted
summing-up the acquired signals, analyzing the summed-up signals to
thereby extract the maternal signal and the fetal signal, including
determining their heart rates, and including detecting health
hazards and in some embodiments, including detecting a uterine
contraction sequence suggesting the need to be hospitalized for
birth giving.
Inventors: |
AMIR; Uri; (Or Yehuda,
IL) ; Malafriev; Oleg; (Rehovot, IL) ; Katz;
Itzhak; (Petach Tikva, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HEALTHWATCH LTD. |
Herzliya |
|
IL |
|
|
Assignee: |
HEALTHWATCH LTD.
Herzliya
IL
|
Family ID: |
51988114 |
Appl. No.: |
15/374393 |
Filed: |
December 9, 2016 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14892538 |
Nov 19, 2015 |
9591983 |
|
|
PCT/IL2014/050493 |
Jun 1, 2014 |
|
|
|
15374393 |
|
|
|
|
62006102 |
May 31, 2014 |
|
|
|
61830077 |
Jun 1, 2013 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/002 20130101;
A61B 5/02438 20130101; A61B 5/04085 20130101; A61B 2503/02
20130101; A41D 2500/20 20130101; A61B 5/7203 20130101; A61B 5/02055
20130101; A61B 5/746 20130101; A61B 5/0006 20130101; A61B 5/02411
20130101; A41D 1/002 20130101; A61B 5/14551 20130101; A61B 5/14542
20130101; A61B 5/0452 20130101; A61B 5/0448 20130101; A61B 5/0816
20130101; A41D 2500/10 20130101; A61B 5/11 20130101; A61B 5/01
20130101; A61B 5/6804 20130101; A61B 5/0011 20130101; A61B 5/6805
20130101; A61B 5/6823 20130101; A41D 1/21 20180101; A61B 5/021
20130101; A61B 5/0472 20130101; A61B 5/0488 20130101; A61B 2562/04
20130101; A61B 2562/0209 20130101; A61B 5/0444 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A41D 1/00 20060101 A41D001/00; A61B 5/0488 20060101
A61B005/0488; A41D 1/20 20060101 A41D001/20; A61B 5/0205 20060101
A61B005/0205; A61B 5/0448 20060101 A61B005/0448 |
Claims
1. A method for maternal and fetal monitoring comprising the steps
of: a) wearing a knitted or interwoven smart maternal garment
having a plurality of textile electrodes integrally knitted or
interwoven therein, said textile electrodes being in communication
flow with a processor; b) acquiring electrical mixed common,
maternal and fetal electrical vital signals from a predetermined
external surface region of a pregnant woman, using a plurality of
textile electrodes integrally knitted or interwoven into a maternal
garment; c) optimally weighted summing-up said acquired mixed
maternal and fetal electrical vital signals to thereby form a
summed-up mixed signal, having a substantially higher SNR than
either of the acquired maternal and fetal electrical vital signals;
d) analyzing the summed-up mixed signal to thereby extract the
maternal signal from said summed-up mixed signal and
maternal-related-parameters thereof; and e) healing the summed-up
mixed signal, including deleting the extracted maternal signal from
said summed-up mixed signal, to thereby form a healed-summed-up
mixed signal; f) analyzing said healed-summed-up mixed signal to
thereby extract a fetal signal from said healed-summed-up mixed
signal and fetal-related-parameters thereof.
2. The method of claim 1, wherein said maternal-related-parameters
are selected from the group including heart rate, oxygen
saturation, respiratory rate, blood pressure, skin temperature and
ECG parameters such as ST elevation and depression.
3. The method of claim 1, wherein said fetal-related-parameters are
selected from the group including heart rate, spatial position of
the heart inside the womb, body spatial orientation inside the
womb, motion inside the womb and body dimensions.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Divisional application of U.S.
Nonprovisional Application No. 14/892,538, filed Nov. 19, 2015,
which is a U.S. national stage entry of International Application
Serial No. PCT/IL2014/050493, filed Jun. 1, 2014, which claims the
benefit under 35 USC 119(e) from U.S. Provisional application Ser.
No. 61/830,077 filed Jun. 1, 2013, the disclosures of which are
included herein by reference.
[0002] This application further claims the benefit under 35 USC
119(e) from U.S. provisional application 62/006,102 filed May 31,
2014, the disclosure of which is included herein by reference.
[0003] This application is also related to PCT application
PCT/IL2013/050963, filed Nov. 23, 2013, entitled "Vertical
conductive textile traces and methods of knitting thereof", and PCT
application PCT/IL2013/050964, filed Nov. 23, 2013, entitled "Float
loop textile electrodes and methods of knitting thereof", all of
which are incorporated herein by reference as if fully set forth
herein
FIELD OF THE INVENTION
[0004] The present invention relates to real-time health monitoring
systems and more particularly, the present invention relates to a
real-time, fetal monitoring system that can be comfortably worn by
a monitored pregnant woman, by wearing a special garment, having at
least one textile electrode embedded within the garment. The unique
textile electrode is configured to detect fetal activity regardless
of the position of the fetus within the mother.
BACKGROUND OF THE INVENTION AND PRIOR ART
[0005] Electrocardiogram (ECG) monitoring has been widely used on
people for detecting medical conditions, such as abnormities
associated with the heart. Signals representing a monitored
person's cardiac activities can be collected through external
electrodes distributed over the person's body. Typically,
electrodes are attached to the skin of the chest and limbs of the
monitored person.
[0006] Monitoring of fetal ECG is performed to detect Fetal
Distress Syndrome, an abnormal condition during gestation or at the
time of delivery marked by altered heart rate or rhythm and leading
to compromised blood flow or changes in blood chemistry.
[0007] High-risk pregnancies are increasingly prevalent given the
higher age at which women become pregnant and the ability to
achieve pregnancies in women with high-risk comorbidities.
Approximately 20-25% of all pregnancies are complicated to some
degree, involving complications such as preterm delivery, fetal
oxygen deficiency, fetal growth restriction and hypertension.
Currently, there is no seamless, non-obtrusive monitoring system to
continuously detect deviations in health status of the pregnant
woman or the fetus.
[0008] The most prominent method for monitoring of the fetal health
condition is monitoring of heart rate variability in response to
activity of the uterus, using cardiotocography (CTG). Despite its
high sensitivity, the specificity of CTG is relatively low.
Generally, in obstetrical practice, the heart rate is determined
using a non-invasively (Doppler) ultrasound probe on the maternal
abdomen or invasively, using an electrode fixed onto the fetal
scalp. The first method is relatively inaccurate, but is applicable
throughout the pregnancy. The latter method is far more accurate
but can only be applied following rupture of the membranes and
sufficient dilatation, restricting its applicability to only the
very last phase of pregnancy.
[0009] Monitoring of the fetal electrocardiogram (ECG), as a
supplement of CTG, may increase the accuracy of detecting fetal
distress. Currently, fetal ECG can be measured reliably by means of
an invasive scalp electrode. Attempts to record the fetal ECG
non-invasively from the maternal abdomen have been hampered by the
low signal to noise ratio (SNR) of the transabdominal ECG, although
several gel-based, non-seamless, and obtrusive commercial products
are available. The abdominal ECG tracings are also dependent on
position of the fetus within the maternal uterus.
[0010] Monitoring of fetal ECG can be difficult due to a number of
reasons. One problem is the co-existence of maternal and fetal
signals in raw signals acquired from a monitored person, as well as
the relatively low fetal signal level relative to the maternal
signal and other noise sources. Another problem is the current
position of the fetus and motion of the fetus.
[0011] Also, typically, either a physician or a nurse is
responsible for the actual placement of the electrodes at the
specific points known to be adequate for accurate ECG measurements.
Typically, the placement of the electrode involves attaching the
electrodes such that is can be only forcibly removed. Furthermore,
typically, to obtain a signal that can be decoded, the electrode
must be applied on a moist surface, typically using gel.
Alternatively, dry attaching electrodes, such as provided by
Orbital Research are used in the art. However, typically, both
types require skin preparations such as cleaning and shaving hairy
skin.
[0012] There is therefore a need and it would be advantageous to
have a real-time, fetal monitoring system that can be comfortably
worn by a monitored pregnant woman. The special garment includes at
least one textile electrode, preferably embedded within the
garment, which textile electrode is configured to detect fetal
activity regardless of the position of the fetus within the mother.
The garment and/or the textile electrodes are either knitted or
interwoven.
[0013] The term "continuous monitoring", as used herein with
conjunction with a health monitoring system, refers to a health
monitoring system, facilitated to monitor a living being
substantially and continuously, day and night, when the monitored
living being is awake or asleep, and active in substantially all
common activities of such living being.
[0014] The term "seamless", as used herein with conjunction with a
wearable device, refers to a device that when worn by an average
person, wherein the device imposes no significant limitation to the
normal life style of that person and preferably not seen by anybody
when used and not disturbingly felt by the user while wearing it.
Furthermore, no activity is required from the monitored person in
order for the system to provide data and a personal-alert when
needed. As the "seamless" characteristics refers also to the user's
behavior, the wearable component is preferably an item that is
normally worn (e.g., underwear) and not some additional item to be
worn just for the purpose of monitoring.
[0015] The terms "underwear", or "leotard", or "garment", as used
herein with conjunction with wearable clothing items, refers to
seamless wearable clothing items that preferably, can be tightly
worn adjacently to the body of a monitored pregnant woman,
typically adjacently to the skin, including underwear, underpants,
leotard and the like.
[0016] The term "tightly" means that specific portions of the
garment where there are electrodes or other sensors that require
certain pressure on the body to obtain a satisfactory signal, are
designed to be as tight as needed. However, all the other parts of
the garment may be not as tight. Optionally, there is a provision
to facilitate tightening or releasing certain portions of the
garment, by built-in straps or other tightening means, so that the
need for more or less tightness does not require the replacement of
the whole garment.
[0017] The term "abnormal", as used herein with conjunction with
health related parameters, refers to a parameter value or one or
more ranges of values which are defined as health hazardous or as
potential health hazardous, when a trend is identified, and
requires attention. For example, the normal blood pressure of an
adult person is in the range 120/80 mm Hg. Typically, a systolic
blood pressure of 130 mm Hg would not be considered hazardous.
However, if a person has a stable mean blood pressure of around
85.+-.10 mm Hg, and suddenly it increases to 125.+-.10 mm Hg, this
may be considered as an abnormal situation. Likewise, if the mean
blood pressure changes gradually and consistently from 85 mm Hg to
120 mm Hg, in a clear trend, a personal-alert should be issued. The
threshold value from which the high blood pressure parameter is
considered as health hazardous may vary and can be set personally
and optionally, dynamically updated, either manually or
automatically, by an adaptation algorithm. Once the high blood
pressure parameter, in the hereinabove example, is set, any value
out of the set threshold value will then be considered as abnormal
for that person.
BRIEF SUMMARY OF THE INVENTION
[0018] The principal intentions of the present invention include
providing a fetal monitoring system that can be comfortably worn by
a monitored pregnant woman, by wearing a special garment, having at
least one textile electrode embedded within the garment. The
textile electrode is configured to detect fetal heart electrical
activity, electrical and/movement activity, regardless of the
position of the fetus within the mother.
[0019] The smart garment with a multiplicity of textile electrodes
is capable of measuring the heart rate of the fetus and preferably,
also the heart rate of the mother. Optionally, the smart garment
with textile electrodes is also capable of measuring at least one
of the following maternal parameters: oxygen saturation,
respiratory rate, skin temperature, blood pressure, ECG parameters
such as ST elevation and depression, and body posture and
movement.
[0020] For heart rate determination of the pregnant woman, at least
one electrode is used. Respiratory rate can be measured using
impedance technology, for example. Oxygen saturation can be
measured using a sternal pulse oximeter with reflectance
technology, for example. Blood Pressure may be determined, for
example, from the Oxygen saturation and ECG parameters analyzed
together. Body posture and movement can be determined using, for
example, an accelerometer embedded in the processor or pressure
sensors, for example textile pressure sensors knitted into the
smart garment
[0021] For heart rate determination of the fetus, at least two
electrodes are used, disposed at the lower abdomen of the mother.
In addition, textile electrodes, capable of detecting mechanical
pressure imposed on the woman's abdomen, may be embedded into the
garment. Thus, continuous monitoring of fetal heart rate and
uterine contractions (CTG) can be achieved.
[0022] The signals collected are transmitted by dedicated yarn,
embedded in the smart garment, to a processor, preferably connected
to the garment using a proprietary docking station snapped onto the
garment. The processor processes and analyzes the signals, using a
specifically designed algorithm. Resulting relevant data is then
transmitted, typically using wireless communication means such as
Wi-Fi or Bluetooth, to a coupled target device, such as a
smartphone or to a preselected center for further medical
supervision and instruction.
[0023] According to the teachings of the present invention, there
is provided a seamless, smart maternal monitoring garment including
a tubular form having variable elasticity, the tubular form having
a first multiplicity of knitted or interwoven lines, wherein each
the line is knitted or interwoven with at least one non-conductive
yarn; and a second multiplicity of conductive textile electrodes
for sensing maternal and fetal electrical vital signals. The
maternal and fetal electrical vital signals are selected from a
group including maternal heart rate, fetal heart rate and
electromyogram (EMG) activities including uterine activities.
[0024] Each conductive textile electrode includes a third
multiplicity of vertically-aligned line segments, wherein each
segment is formed within the knitted or interwoven lines with a
non-conductive yarn and a conductive yarn. Each conductive textile
electrode further includes a skin-side face configured to
electrically conduct the signal from a predetermined external
surface region of a pregnant woman. The predetermined external
surface region is selected from a group including the abdomen, the
perineum and buttocks of the pregnant woman.
[0025] Each conductive textile electrode is adapted to be in
communication flow with a processor, adapted to process and analyze
the electric signals acquired by the textile electrodes.
[0026] The second multiplicity of conductive textile electrodes
includes a preconfigured number of measuring electrodes and a
preconfigured number of reference electrodes. Each measuring
electrode is paired with at least one reference electrode. Thereby,
the number of differential measurements produced from a single
measuring electrode may be more than one, i.e., the number of
differential measurements produced is the number of reference
electrodes that the particular measuring electrode is paired with,
each pairing providing a different differential measurement.
[0027] Furthermore, each given conductive textile electrode, in a
specific measurement instance, may be paired with a preconfigured
number of other conductive textile electrodes, wherein in each
pairing, the given conductive textile electrode may serve either as
a measuring electrode or as a reference electrode, thereby
facilitating substantial increase in the number of differential
measurements acquired, in that specific measurement instance,
beyond the second multiplicity of the conductive textile
electrodes.
[0028] The measuring electrodes and the reference electrodes are
positioned, within the maternal garment, in preconfigured
locations. The position of the measuring electrodes and the
reference electrodes are preconfigured to thereby optimize the
spatial coverage of the uterine.
[0029] Preferably, the pairing of the measuring electrodes and
respective reference electrodes is preset using the processor. The
number of measuring electrodes, the number of reference electrodes
and the pairing thereof are preset to thereby optimize the signal
to noise (SNR) ratio.
[0030] The tubular form has a designated knitting or interweaving
density, and wherein one or more designated regions have a knitting
or interweaving density that is higher than the designated knitting
or interweaving density of the tubular form, thereby providing the
variable elasticity, to enable stable conductive contact of the
skin-side face of each the electrode with the skin of the pregnant
woman.
[0031] Preferably, the maternal and fetal monitoring is performed
continuously, day and night, while performing everyday life
chores.
[0032] Preferably, the processor is adapted to alert at least one
preconfigured receiving entity, upon detecting a health hazard. The
preconfigured receiving entity is selected from the group including
a smart personal electronic device of the pregnant woman, a smart
personnel electronic device of another person, a medical personal,
and a remote center.
[0033] According to further teachings of the present invention,
there is provided a method for maternal and fetal monitoring
including the steps of: [0034] a) Wearing a knitted or interwoven
smart maternal garment having a plurality of textile electrodes
integrally knitted or interwoven therein, the textile electrodes
being in communication flow with a processor. [0035] b) Acquiring
electrical mixed common, maternal and fetal electrical vital
signals from a plurality of external surface regions of a pregnant
woman, respectively using a plurality of textile electrodes
integrally knitted or interwoven into a maternal garment. [0036] c)
Optimally-weighted summing-up the acquired mixed maternal and fetal
electrical vital signals to thereby form a summed-up mixed signal,
having a substantially higher SNR than either of the acquired
maternal and fetal electrical vital signals. [0037] d) Analyzing
the summed-up mixed signal to thereby extract a maternal signal
from the summed-up mixed signal and maternal-related-parameters
thereof. [0038] e) Healing the summed-up mixed signal, including
deleting the extracted maternal signal from the summed-up mixed
signal, to thereby form a healed-summed-up mixed signal. [0039] f)
Analyzing the healed-summed-up mixed signal to thereby extract a
fetal signal from the healed-summed-up mixed signal and
fetal-related-parameters thereof.
[0040] The maternal-related-parameters are selected from the group
including heart rate, oxygen saturation, respiratory rate, blood
pressure, skin temperature and ECG parameters such as ST elevation
and depression.
[0041] The fetal-related-parameters are selected from the group
including heart rate, spatial position of the heart inside the
womb, body spatial orientation inside the womb, motion inside the
womb and body dimensions.
[0042] According to further teachings of the present invention,
there is provided a method for maternal and fetal monitoring
including the steps of: [0043] a) Wearing a knitted or interwoven
smart maternal garment having a plurality of textile electrodes
integrally knitted or interwoven therein, the textile electrodes
being in communication flow with a processor. [0044] b) Acquiring
electrical mixed common, maternal and fetal electrical vital
signals from a plurality of external surface regions of a pregnant
woman, respectively using a plurality of textile electrodes
integrally knitted or interwoven into a maternal garment. [0045] c)
Optimally-weighted summing-up the acquired mixed maternal and fetal
electrical vital signals to thereby form a summed-up maternal
signal, having a substantially higher SNR than either of the
acquired maternal and fetal electrical vital signals. [0046] d)
Analyzing the summed-up maternal signal to thereby extract a
maternal signal from the summed-up maternal signal. [0047] e)
Healing the acquired mixed maternal and fetal electrical vital
signals, including deleting the extracted maternal signal from the
respective acquired mixed maternal and fetal electrical vital
signal, to thereby form a plurality of healed-maternal ECG signals.
[0048] f) Optimally-weighted summing-up the healed-maternal ECG
signals to thereby form a summed-up coherent fetal signal, having a
substantially higher SNR than either of the healed-maternal ECG
signals. [0049] g) Analyzing the summed-up coherent fetal signal to
thereby extract a fetal signal from the summed-up coherent fetal
signal.
[0050] Optionally, the method further includes analyzing the
summed-up coherent fetal signal to thereby extract the EMG signal
formed by electromyogram (EMG) activities including uterine
activities, from the summed-up coherent fetal signal.
[0051] The extracting and analyzing of the maternal signal from the
summed-up maternal signal includes: [0052] a) Detecting the peaks
in the maternal QRS complexes using the summed-up maternal signal,
the maternal QRS complexes peaks being substantially stronger than
the fetal QRS complexes. [0053] b) Determining the boundary of each
detected maternal QRS complex. [0054] c) Analyzing the summed-up
maternal signal to thereby extract the maternal signal and
determine the maternal HR. [0055] d) Analyzing each detected
maternal QRS complex to thereby detect health hazardous data.
[0056] The extracting and analyzing of the fetal signal from the
summed-up coherent fetal signal includes: [0057] a) Detecting the
peaks of the maternal QRS complexes in the summed-up maternal
signal, the maternal QRS complexes peaks being substantially
stronger than the fetal QRS complexes. [0058] b) Determining the
boundary of each detected maternal QRS complex. [0059] c) Deleting
each detected maternal QRS complex from the respective acquired
mixed maternal and fetal electrical vital signal and filling the
gap, thereby forming a respective healed-maternal ECG signal.
[0060] d) Optimally-weighted summing-up the healed-maternal ECG
signals to thereby form a summed-up coherent fetal signal, having a
substantially higher SNR than either of the healed-maternal ECG
signals. [0061] e) Detecting the peaks of fetal QRS complexes in
the summed-up coherent fetal signal. [0062] f) Determining the
boundary of each detected fetal QRS complex. [0063] g) Analyzing
the summed-up coherent fetal signal to thereby determine the fetal
HR. [0064] h) Analyzing each detected fetal QRS complex to thereby
detect health hazardous data.
[0065] The extracting and analyzing of the EMG signal from the
summed-up coherent fetal signal includes: [0066] a) Detecting the
peaks in the maternal QRS complexes in the summed-up maternal
signal; [0067] b) Determining the boundary of each detected
maternal QRS complex. [0068] c) Deleting each detected maternal QRS
complex from the respective acquired mixed maternal and fetal
electrical vital signal and filling the gap, thereby forming a
respective healed-maternal ECG signal. [0069] d) Detecting the
peaks of the fetal QRS complexes in the summed-up coherent fetal
signal. [0070] e) Determining the boundary of each detected fetal
QRS complex. [0071] f) Deleting each detected fetal QRS complex
from the summed-up coherent fetal signal and filling the gap,
thereby forming an EMG summed-up signal. [0072] g) Analyzing the
EMG summed-up signal.
[0073] The method of filling the gap includes, for example, by
linear interpolation or spline.
[0074] The summed-up coherent fetal signal may contain more than
one fetus and wherein the fetal QRS complexes of the signal of each
fetus is separated based on different heart rate and/or different
phase normal or inverted QRS Complex. The separation of the signal
of each fetus may be performed using Fourier transform.
[0075] It should be noted that the maternal garment is worn without
attaching either of the electrodes, regardless of the precise
bodily positioning of each electrode, regardless of the
chronological stage of the pregnancy, and regardless of the amount
of stretching of the tubular form and of each electrode.
BRIEF DESCRIPTION OF THE DRAWINGS
[0076] The present invention will become fully understood from the
detailed description given herein below and the accompanying
drawings, which are given by way of illustration and example only
and thus not limitative of the present invention:
[0077] FIG. 1 schematically illustrates a smart maternal monitoring
garment for maternal and fetal monitoring, being an exemplary
underwear monitoring-garment, according to embodiments of the
present invention.
[0078] FIG. 2a is a side view illustration of the underpants shown
in FIG. 1, worn by a monitored pregnant woman.
[0079] FIG. 2b is a front view of the underwear monitoring-garment,
as shown in FIG. 2a.
[0080] FIG. 2c is a back view of the underwear monitoring-garment,
as shown in FIG. 2a.
[0081] FIG. 3 is a front perspective view illustration of the
system shown in FIG. 1, integrated into a leotard-type garment,
worn by a monitored pregnant woman.
[0082] FIG. 4 is a front perspective view illustration of the
system shown in FIG. 1, integrated into a plain tubular garment,
wrapped around the abdominal region of a monitored pregnant
woman.
[0083] FIG. 5 is a schematic block diagram of one embodiment of the
garment-control device shown in FIGS. 1, 2a and 2b.
[0084] FIG. 6 schematically illustrates a seamless wearable fetal
monitoring system including a smart leotard, being an exemplary
underwear monitoring-garment, according to other embodiments of the
present invention.
[0085] FIGS. 7a-7d show examples of 4 mixed maternal and fetal
electrical signals, each provided by a respective measuring textile
electrode.
[0086] FIG. 7e shows the 4 mixed maternal and fetal electrical
signals illustrated in FIGS. 7a-7d, overlaid on a mutual time axis,
as provided simultaneously by respective four measuring textile
electrodes.
[0087] FIG. 8 is a schematic flowchart diagram outlining an example
method for detecting, separating and analyzing a maternal QRS
signal.
[0088] FIG. 9 shows the flattened, summed-up mixed maternal and
fetal electrical signal, after optimally weighted summing-up the
four signals shown in FIGS. 7a-7d.
[0089] FIG. 10 shows the maternal QRS complexes peaks as detected
in the derivative of the summed-up signal, thereby yielding the
maternal heart rate.
[0090] FIG. 11 shows the maternal QRS complexes peaks as overlaid
over the summed-up signal.
[0091] FIG. 12a shows a magnification of a selected time interval
of the summed-up signal, as shown in FIG. 11.
[0092] FIG. 12b shows an example maternal QRS complex that can be
medically analyzed.
[0093] FIG. 13 is a schematic flowchart diagram outlining an
example method for detecting, separating and analyzing the fetal
QRS signals.
[0094] FIG. 14 shows the fetal QRS complexes peaks as detected in
the derivative of the summed-up coherent fetal signal, thereby
yielding the heart rate of the fetus.
[0095] FIG. 15 shows the fetal QRS complexes peaks as overlaid over
one of the summed-up coherent fetal signal.
[0096] FIG. 16 is a schematic flowchart outlining an example method
for detecting and analyzing an EMG signal.
DETAILED DESCRIPTION OF THE INVENTION
[0097] The present invention will now be described more fully
hereinafter with reference to the accompanying drawings, in which
preferred embodiments of the invention are shown. This invention
may, however, be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein; rather,
these embodiments are provided, so that this disclosure will be
thorough and complete, and will fully convey the scope of the
invention to those skilled in the art.
[0098] An embodiment is an example or implementation of the
inventions. The various appearances of "one embodiment," "an
embodiment" or "some embodiments" do not necessarily all refer to
the same embodiments. Although various features of the invention
may be described in the context of a single embodiment, the
features may also be provided separately or in any suitable
combination. Conversely, although the invention may be described
herein in the context of separate embodiments for clarity, the
invention may also be implemented in a single embodiment.
[0099] Reference in the specification to "one embodiment", "an
embodiment", "some embodiments" or "other embodiments" means that a
particular feature, structure, or characteristic described in
connection with the embodiments is included in at least one
embodiments, but not necessarily all embodiments, of the
inventions. It is understood that the phraseology and terminology
employed herein is not to be construed as limiting and are for
descriptive purpose only.
[0100] Methods of the present invention may be implemented by
performing or completing manually, automatically, or a combination
thereof, selected steps or tasks. Meanings of technical and
scientific terms used herein are to be commonly understood as to
which the invention belongs, unless otherwise defined. The present
invention can be implemented in the testing or practice with
methods and materials equivalent or similar to those described
herein.
[0101] It should be noted that the present invention will often be
described in terms of the monitoring-garment being an underpants,
but the present invention is not limited to an underpants being the
monitoring-garment, and other types of garment, at least partially
worn adjacently to the body of the monitored pregnant woman can be
used as a monitoring-garment.
[0102] It should be noted that the present invention will be
described in terms of the optional mobile device being a
smart-phone, but the mobile device of present invention is not
limited to being a smart-phone, and includes all types of mobile
devices having a central processing unit and memory, including a
mobile phone, laptop, a PDA, a processing pad, etc., all having
Bluetooth or any other wireless communication capabilities.
According to the teachings of the present invention, there is
provided an independent, seamless and preferably substantially
continuous health monitoring system, designed for use by a healthy
living being but also suitable for non-healthy living being.
[0103] Reference now made to the drawings. FIG. 1 illustrates a
seamless wearable fetal monitoring system 100 including a smart
garment 200 worn by a monitored pregnant woman 10, according to
embodiments of the present invention, smart garment 200 being an
exemplary underwear monitoring-garment. Fetal monitoring system 100
further includes a garment-control device 110 and preferably, a
receiving device such as a mobile device 300, having a
remote-processor 310, according to embodiments of the present
invention.
[0104] FIG. 2a is a side view illustration of smart garment 200,
worn by a monitored pregnant woman 10, smart garment 200 being an
exemplary leotard. FIG. 2b is a front view illustration of smart
leotard 200 and FIG. 2c is a back view illustration of smart
leotard 200, as shown in FIG. 2a.
[0105] Smart garment 200 is a non-limiting, exemplary
monitoring-garment item, wherein smart garment 200 is, preferably,
a knitted garment and wherein one or more textile electrodes 210
are knitted there within, when smart garment 200 is fabricated. The
textile electrodes 210 are made of conductive yarn, wherein
electrocardiogram (ECG) signals, being detected by textile
electrodes 210. The signals are then transferred via knitted
conductive traces along the knitted fabric to an innovative device,
which analyzes the data in real-time.
[0106] In some embodiments textile electrodes 210 are interwoven
and in some embodiments smart garment 200 is interwoven. Textile
electrodes 210 and smart garment 200 will be described herein, with
no limitations, as being knitted, but textile electrodes 210 and
garment 200 may also be interwoven, within the scope of the present
invention.
[0107] Typically, textile electrodes 210 are integrated in various
positions within smart garment 200, in order to cope with the
changing of position and the growing of the fetus inside the
mother's womb. Textile electrodes 210 acquire mixed electrical
maternal and fetal vital signals, and possibly EMG signals.
Garment-control device 110 reads the mixed signals from the various
textile electrodes 210 and in some embodiments, garment-control
device 110 selects a signal determined to be the "best signal",
according to preconfigured criteria. For example, signals that best
match a master expected signal ("gold-standard" fetal data).
[0108] However, preferably, garment-control device 110 reads the
mixed signals from a multiplicity of textile electrodes 210, makes
(optionally) an initial sorting of the multiplicity of signals, and
optimally performs a weighted summing-up of the acquired mixed
electrical maternal and fetal vital signals, to thereby form a
summed-up electrical signal having a substantially higher SNR than
either of the acquired mixed electrical maternal and fetal
electrical vital signals.
[0109] Typically, textile electrodes 210 are surface-to-surface
contact textile sensors, used for measuring maternal and fetal
electrical vital signals such as ECG signals and other vital
signals, such as cardiotocography signals and other medical
measurements on the skin, without any skin preparation such as
needed with current wet electrode (usually gel) as well as on hairy
skin (currently, usually being shaved).
[0110] The multiplicity of textile electrodes 210 may include a
preconfigured number of measuring electrodes 212 and reference
electrodes 214 that may be selectively paired, for example using
garment-control device 110, to form ECG leads. Each measuring
electrodes 212 is paired with at least one reference electrode 214,
facilitating acquiring more ECG differential measurements than the
number of textile electrodes 210 that serve as measuring electrodes
212. The number textile electrodes 210 that serve as measuring
electrodes 212 may be controlled, for example using garment-control
device 110. Hence, which textile electrode 210 serves as measuring
electrode 212 and with which one or more reference electrode 214
that measuring electrode 212 is paired, can be pre-programed and
re-programed. Using this unique capability, seamless wearable fetal
monitoring system 100 may be suited, for example, to the
advancement of the pregnancy and abdomen dimensions, or for any
other reason.
[0111] It should be noted that the annotation of measuring
electrodes 212 and reference electrodes 214 in the Figures are
shown by way of example only, with no limitations. Textile
electrodes 210 may be placed at predetermined external surface
regions selected from a group including the abdomen, the perineum
and buttocks of the pregnant woman.
[0112] Each textile electrode 210 is operatively connected to a
preferably detachable garment-control device 110, by a conductive
trace 220 conductive stripes or any other electric wiring.
Optionally, conductive traces 220 are also knitted into smart
garment 200, when smart garment 200 is fabricated. Alternatively,
conductive traces 220 are attached to smart garment 200.
[0113] Typically, smart garment 200 looks like regular underpants
and preferably, the textile electrode 210 are embedded therein. A
pregnant woman 10 can easily wear the underpants in any situation
where he or she is used to. However, smart garment 200 may be
replaced by a leotard-type smart garment 202, as shown in FIG. 3,
or a tubular smart garment 204, as shown in FIG. 4, or other forms.
In the example shown, leotard-type smart garment 202 includes a
textile electrode 211 that is positioned proximal to the mother's
heart, to thereby obtain a good maternal ECG signal. After wearing
the smart garment, no attaching of electrodes or placement
adjustments are required from the user. Simply wear the smart
garment and activate the system.
[0114] Reference is also made to FIG. 5, a schematic block diagram
of one embodiment of garment-control device 110. Garment-control
device 110 is also mounted onto garment-body 201 of a smart garment
200 is garment-control device 110, wherein traces 220 interconnect
all of the sensors (210, 212 and 214) with garment-control device
110, optionally by traces 220 knitted into monitoring-garment 200.
Garment-control device 110 includes a garment-processor 112 and a
preferably replaceable and/or rechargeable battery 180, wherein
garment-control device 110 and battery 180 are preferably
removable, to allow machine washing of the smart garment.
Rechargeable battery 180 may be part of garment-control device 110
of separated from garment-control device 110. Preferably,
garment-control device 110 further includes a transmitter 114,
typically short range transmitter such as Bluetooth or Wi-Fi,
facilitating wireless communication between garment-processor 112
and remote-processor 310 of a mobile device 300. Optionally,
garment-control device 110 further includes an alerting unit
116.
[0115] In one embodiment of the present invention, garment-control
device 110 transmits the sensed data, as provided by the sensors
(210, 211 and 212), to remote-processor 310 of mobile device 300,
via transmitter 114. In other embodiments of the present invention,
garment-processor 112 analyzes the sensed data obtained by one or
more of the sensors (210, 211 and 212) and prevents sensed data
that is well within a preconfigured range of normal parameter, from
being transmitted by transmitter 114 to remote-processor 310.
Thereby, substantially reducing the transmittal time and saving in
transmittal power.
[0116] Optionally, embedded garment-processor 112 has a filtering
function to substantially limit the transmissions to the mobile
device. One part of that function is limiting the transmission,
when there are no problems detected and selecting only the
suspected abnormal data to be transmitted. This function
significantly reduces the amount of energy needed, thus preserving
the battery power. In addition, the algorithms determine the
sensing rate: while in normal state the rate may be low, when
sensed data is closer to abnormality values, the sensing and
transmission rates are higher.
[0117] In some preferred embodiments of the present invention,
garment-processor 112 analyzes the sensed data obtained by one or
more of the sensors (210, 211 and 212) to thereby determine if a
health hazardous situation has occurred. In such an event,
garment-processor 112 activates an alerting unit 116, coupled to
operate with garment-processor 112, to thereby provide a
personal-alert to person 10 or any other predetermined receiving
unit, including receiving unit of medical care personal. The
personal-alert may be in the form of an audio sound, a light
indication, any other form known in the art, or a combination
thereof.
[0118] Optionally, garment-control device 110 is operatively
anchored in a corresponding docking station that is attached to
monitoring-garment 100, and operatively attached to traces 220.
[0119] As indicated hereinabove, fetal monitoring system 100 of the
present invention preferably includes a mobile device 300, having a
remote-processor 310. Remote-processor 310 receives sensed data
from monitoring-garment 100, preferably, at least partially
processed, and may further analyze the received data, as needed,
and determines if a health hazardous situation, that justifies the
issuing of a personal-alert has occurred. In such an event,
remote-processor 310 activates an alarm indicator 116, coupled to
operate with remote-processor 310, to thereby alarm person 10 with
a personal-alert 350. The personal alert may be in the form of an
audio sound, at least one image frames, a video, an SMS, or any
other form known in the art, or a combination thereof.
[0120] In variations of the present invention, the definition of
the abnormality of the physiological or chemical parameter is
personally adaptive, wherein the "normal" health state of a
particular monitored living being is personally set. In variations
of the present invention, the definition of the abnormality is
dynamically adaptable per the changing state over time of the
living being.
[0121] Upon detecting abnormal health related parameters, or an
abnormal state determined as a result from an analysis of combined
inputs acquired from different sensors, or from a trends analysis,
remote-processor 310 sends a personal-alert through smart-phone
300. Optionally or additionally, remote-processor 310 sends
personal-alert information to a predetermined external recipient.
Optionally, remote-processor 310 analyzes and determines the
correlation between the detected parameters of two or more of the
detected, thereby creating correlated parameters. When the detected
correlated parameters are determined to be abnormal, the alerting
unit is operatively activated to alert one or more predetermined
alert receiving entities.
[0122] It should be further noted that some of the processing tasks
may be performed at a remote monitoring center. The
garment-processor 112 or mobile device 300 may send the data
(sensed data or at least partially analyzed sensed data) to any
remote processor, which can further process the information,
compare the obtained data to corresponding data obtained from other
monitored people, make statistics-based decisions and other
decision-making issues to improve alerts sensitivity and
specificity (for example by detecting suspicious trends that did
not trigger the automatic alert but a physician may want to further
check the person) and providing information for assisting the
treatment of the living being once getting to a treating
facility.
[0123] Preferably, the health monitoring and self-alert system
includes sensors for detecting the characteristics of the physical
activities and posture of the living being, for example,
acceleration sensors 170 (see FIG. 5), pressure sensors,
orientation sensors, etc. Acceleration sensors 170 may be
integrated within garment processor 110, and/or at other
preconfigured locations in garment-body 201.
[0124] FIG. 6 schematically illustrates a seamless wearable fetal
monitoring system 101 including a smart garment 400, being an
exemplary underwear monitoring-garment, according to other
embodiments of the present invention. Smart fetal monitoring system
101 is similar to smart fetal monitoring system 100, but further
includes at least one textile pressure sensor 450 for detecting
activity of the uterus, such as contractions. Textile pressure
sensor 450 may be embodied as separate detectors and/or embodied
within ECG electrode (or other textile sensors) 210 to form a
multi-purpose sensor 410. The textile pressure sensor may be
embodied as a combination of more than one sensing element 452,
within ECG electrode (or other textile sensors) 210.
[0125] In variations of the present invention, motion of the fetus
within the mother's uterus, is detected, using multiple ECG
electrodes. The SNR ration of each ECG electrode is measure whereas
it is assumed that the heart of the fetus is spatially positioned
closest to the electrode having the best SNR. As the fetus moves,
the spatially position of the heart of the fetus is moving to be
closer to a different ECG electrode. Since to position of each ECG
electrode with respect to the mother's uterus is substantially
fixed and known, these changes in the SNR of the ECG electrodes can
be analyze to proximate the spatial position of the heart of the
fetus as well as the position and posture-orientation of the fetus
itself.
[0126] It is an aspect of the present invention to provide methods
for maternal and fetal monitoring, using seamless wearable fetal
monitoring system 100 and variations thereof. The method assumes M
textile electrodes 210, some of which M textile electrodes 210 are
preset to serve as reference electrodes 214 and the rest, N textile
electrodes 210, are preset to serve as measuring electrodes 212,
wherein the presetting is performed using garment-control device
110.
[0127] To start using seamless wearable fetal monitoring system 100
a pregnant woman 10 wears a knitted or interwoven smart maternal
garment 200, having of textile electrodes 210 integrally knitted or
interwoven therein, the textile electrodes 210 being in
communication flow with garment-control device 110, and activates
fetal monitoring system 100. Garment-control device 110 starts
acquiring electrical mixed common, maternal and fetal electrical
vital signals from a predetermined external surface region of a
pregnant woman, using a plurality of textile electrodes integrally
knitted or interwoven into a maternal garment. The monitoring may
be performed continuously, 24/7.
[0128] It should be noted that smart maternal garment 200 is worn
without attaching either of the textile electrodes 210, regardless
of the precise bodily positioning of each textile electrode 210,
regardless of the chronological stage of the pregnancy, and
regardless of the amount of stretching of the textile tubular form
and of each textile electrode 210.
[0129] Reference is now made to FIGS. 7a-7e. FIG. 7a shows a graph
601a of an example of a first mixed maternal and fetal electrical
signal, as provided simultaneously by a respective measuring
textile electrode 212. FIG. 7b shows a graph 601b of an example of
a second mixed maternal and fetal electrical signal, as provided
simultaneously by a respective measuring textile electrode 212.
FIG. 7c shows a graph 601c of an example of a third mixed maternal
and fetal electrical signal, as provided simultaneously by a
respective measuring textile electrode 212. FIG. 7d shows a graph
601d of an example of a fourth mixed maternal and fetal electrical
signal, as provided simultaneously by a respective measuring
textile electrode 212. FIG. 7e shows a graph 601e of the 4 mixed
maternal and fetal electrical signals illustrated in FIGS. 7a-7d,
overlaid on a mutual time axis, as provided simultaneously by the
respective four measuring textile electrodes. The four raw signals
have different amplitudes, and different phases. Empirically, with
no limitations, the following observations are made: [0130] The
maternal and fetal signals are not correlated. Although normally,
their HR's are different, their ranges may be partially
overlapping. [0131] The maternal and fetal ECG signal may ride on
slow (<0.5 Hz) but very strong signals produced, for example, by
muscles contraction, this low frequency signal interferes with
reliable detection of the QRS complexes peaks. To substantially
improve the signal flatness, polynomial filtering may be used,
typically along with a derivative evaluation, wherein each raw
signal is approximated by a polynomial and its derivative can be
evaluated analytically. In some embodiments the polynomial
filtering method combines Savitzky-Golay filtering and smoothing
spline. [0132] Typically, with no limitations, over 10 measuring
textile electrodes 212 are used to improve SNR, wherein at least 2
measuring textile electrodes 212 are disposed proximal to the heart
of the fetus.
[0133] Reference is now also made to FIG. 8, a schematic flowchart
diagram 600 outlining an example method for detecting, separating
and analyzing a maternal QRS signal from a multiplicity of
simultaneously sensed mixed ECG signals. The maternal QRS complexes
being substantially stronger than the fetal QRS complexes, the
maternal QRS complexes are detected firstly.
[0134] Method 600 includes the following steps: [0135] Step 610:
acquiring N signals as sensed by respective N selected measuring
textile electrodes 212. [0136] Each measuring textile electrodes
212 senses a mixed ECG raw signal. A mixed ECG raw signal includes
a maternal ECG signal, a fetal ECG signal, signals of
electromyogram (EMG) activities including uterine activities, and
other signals that at least a portion of them are referred to as
noise. [0137] Step 620: filtering the acquired signals. [0138] Each
sensed mixed ECG raw signal is preferably filtered to substantially
reduce the noise. To substantially improve the signal flatness,
polynomial filtering may be used, wherein each raw signal is
approximated by a polynomial and its derivative can be evaluated
analytically. In some embodiments the polynomial filtering method
combines Savitzky-Golay filtering and smoothing spline. Typically,
with no limitations, the filtering of each sensed mixed ECG raw
signal yields to signals: y.sub.d, a derivative signal that
contains the QRS complexes peaks data; and y.sub.f, representing
the filtered signal. [0139] Step 630: detecting derivative peaks.
[0140] Using the derivative signal y.sub.d, garment-control device
110 detects derivative peaks that correspond to the maternal QRS
complexes peaks of the respective sensed mixed ECG raw signal.
[0141] Step 640: Optimally aligning the respective peaks of the N
signals. [0142] Garment-control device 110 reads all the filtered
mixed signals and respective derivative signals, makes (optionally)
an initial sorting of the multiplicity of signals, and optimally
calculates the best maternal QRS peaks alignment of the mixed ECG
raw signals. Thereby, the phase shift of each mixed ECG raw signal
is obtained. [0143] To improve phase alignment process an
analytical (complex) signal, such as Hilbert transform, may be
used. [0144] Step 650: summing-up the N signals. [0145]
Garment-control device 110 performs a weighted summing-up of the
filtered mixed signals, after shifting each filtered mixed signal
by the respective calculated phase shift, thereby forming a
summed-up coherent maternal signal having a substantially higher
SNR than either of the acquired mixed electrical maternal and fetal
vital signals. [0146] Step 660: determining the boundary of
maternal QRS complexes. [0147] Normally, each QRS complex starts
from a first minimum point, reaches maximum and ends at a second
minimum point. The first and second minimum points of each QRS
complex are determined by garment-control device 110. [0148] Step
670: analyzing the maternal QRS complexes. [0149] Garment-control
device 110 analyzes, for example by performing a morphologically
analysis, and to determine the maternal HR and possibly detect
health hazardous data. [0150] {end of steps details of process
600}
EXAMPLE
[0151] In the example shown in FIG. 7e, a graph 601e of 4 overlaid
mixed maternal and fetal example signals, as provided
simultaneously by respective four measuring textile electrodes 212,
were shown.
[0152] Reference is also made to FIG. 9, showing the flattened,
summed-up mixed maternal and fetal electrical signal, after the
summing-up process (step 650) the four signals. The summed-up
maternal signal is coherent, with good SNR and the maternal QRS
complexes can be easily observed.
[0153] FIG. 10 shows an example graph 603 of the maternal QRS
complexes peaks as detected in the derivative of the summed-up
maternal signal, thereby yielding the maternal heart rate. In the
example shown, the maternal HR is about 80.
[0154] The first and second minimum points of each maternal QRS
complex are determined by garment-control device 110, and each
maternal QRS complex is disposed in the respective position in each
respective filtered ECG signal. FIG. 11 shows an example graph 604
of the maternal QRS complexes as overlaid over the summed-up
maternal signal. FIG. 12a shows a magnification 605 of a selected
time interval of the summed-up maternal signal, as shown in FIG.
11, and FIG. 12b shows an example graph 606 of a maternal QRS
complex that can be medically analyzed. After the QRS complexes
peaks are identified and localized, each QRS complex can be
analyzed, for example morphologically, and their parameters can be
evaluated using methods that cause only slight distortion. [0155]
{end of example }
[0156] Once the maternal QRS complexes have been found and
analyzed, they can be removed either from each of the sensed mixed
ECG raw signals or each of the filtered signals. Once removed, a
similar process can be executed in order to detect and analyze the
fetal QRS complexes.
[0157] Reference is also made to FIG. 13, showing a schematic
flowchart diagram 700 outlining an example method for detecting,
separating and analyzing a fetal QRS signal from a multiplicity of
simultaneously sensed mixed ECG signals. To begin with, steps
610-660 of method 600 are performed. Then, the overlaid maternal
QRS complexes, as respectively overlaid over summed-up ECG signal,
as shown in FIG. 11, removed from the respective raw ECG signals,
in a process referred to herein as healing, as described here
below.
[0158] Hence, after steps 610-660 of method 600 are performed,
method 700 proceeds with the following steps: [0159] Step 710:
healing the N filtered ECG signals. [0160] Garment-control device
110 deletes the maternal QRS complexes from the respective raw ECG
signals leaving a gap therein. The gaps formed may be filled by
linear interpolation, spline or any other known method. The
deleting of QRS complexes from respective raw ECG signals and then
filling the gaps formed, is referred to herein as a healing
process. A signal yield from the healing process of this step is
referred to as a healed-maternal ECG signal. [0161] Step 720:
filtering the acquired signals. [0162] Each healed-maternal ECG
signal is preferably filtered to substantially reduce the noise. To
substantially improve the signal flatness, polynomial filtering may
be used, wherein each healed-maternal ECG signal is approximated by
a polynomial and its derivative can be evaluated analytically. In
some embodiments the polynomial filtering method combines
Savitzky-Golay filtering and smoothing spline. Typically, with no
limitations, the filtering of each healed-maternal ECG signal
yields to signals: y.sub.d2, a derivative signal that contains the
QRS complexes peaks data; and y.sub.f2, representing the filtered
signal. [0163] Step 730: detecting derivative peaks. [0164] Using
the derivative signal y.sub.d2, garment-control device 110 detects
derivative peaks that correspond to the fetal QRS complexes peaks
of the respective healed-maternal ECG signal. [0165] Step 740:
Optimally aligning the respective peaks of the N signals. [0166]
Garment-control device 110 reads all filtered healed mixed signals
y.sub.f2 and respective derivative healed signals y.sub.d2, makes
(optionally) an initial sorting of the multiplicity of signals, and
optimally calculates the best fetal QRS peaks alignment of the
healed-maternal ECG signals. Thereby, the phase shift of each
healed-maternal ECG signal is obtained. [0167] To improve phase
alignment process an analytical (complex) signal, such as Hilbert
transform, may be used. [0168] Step 750: summing-up the N signals.
[0169] Garment-control device 110 performs a weighted summing-up of
the filtered healed signals, after shifting each filtered mixed
signal by the respective calculated phase shift, thereby forming a
summed-up coherent fetal signal having a substantially higher SNR
than either of the healed-maternal ECG signal. [0170] Step 760:
determining the boundary of fetal QRS complexes. [0171] Normally,
each QRS complex starts from a first minimum point, reaches maximum
and ends at a second minimum point. The first and second minimum
points of each QRS complex are determined by garment-control device
110. [0172] Step 770: analyzing the fetal QRS complexes. [0173]
Garment-control device 110 analyzes, for example by performing a
morphologically analysis, and to determine the fetal HR and
possibly detect health hazardous data. [0174] {end of steps details
of process 700}
EXAMPLE
[0175] Continuing from the maternal example, reference is also made
to FIG. 14, showing an example graph 701 of the fetal QRS complexes
peaks as detected in the derivative of the summed-up coherent fetal
signal, thereby yielding the fetal heart rate.
[0176] The first and second minimum points of each fetal QRS
complex are determined by garment-control device 110, and each
fetal QRS complex is disposed in the respective position in each
respective filtered ECG signal. FIG. 15 shows an example graph 702
of the fetal QRS complexes as overlaid over one of the four signals
composing the healed-maternal ECG signal. [0177] {end of example
}
[0178] Reference is also made to FIG. 16, showing a schematic
flowchart diagram 800 outlining an example method for detecting and
analyzing muscles contraction such as uterine contractions, herein
referred to as EMG signal analysis. To begin with, steps 610-660 of
method 600 and 710-760 of method 700 are performed. Then, method
800 proceeds with the following steps: [0179] Step 810: healing the
summed-up coherent fetal signal. [0180] Garment-control device 110
deletes the fetal QRS complexes from the summed-up coherent fetal
signal, for example, leaving a gap therein. The gaps formed may be
filled by linear interpolation, spline or any other known method. A
signal yield from the healing process of this step is referred to
as an EMG signal. [0181] Step 820: analyzing the EMG signal. [0182]
Garment-control device 110 analyzes, for example by performing a
morphologically analysis, and to determines if the uterine is
contracting at a rate and amplitude that requires hospitalization
for birth giving. [0183] (end of steps details of process 800)
[0184] Preferably the health monitoring and self-alert system,
including monitoring garment 100, complies with to the IEEE 802.15
standard or an updated standard and FCC Medical Body Area Network
(MBAN) systems or an updated standard.
[0185] It should be further noted that the monitoring of the health
condition is configured to perform continuously. Personal-alerts
may be generated immediately as a dangerous situation is detected.
The user does not have to perform any activity action in order to
get the alert. For the sake of clarity, activity may be required at
installation time, but not during monitoring.
[0186] It should be further noted that personal-alerts can be
issued to the monitored being and/or to an external entity, such as
an emergency center, a close relative, etc. The personal-alert can
be transmitted to a computer, a telephone and/or any other
communication device.
[0187] In variation if the present invention, the monitoring
garment (200, 202, 204 or 400) includes a generally vertical zipper
(not shown), wherein textile electrodes 210 are knitted therein and
are individually operatively connected to garment-control device
110. However, some electrodes may require crossing the zipper. To
overcome the problem conductive stripes or line traces 220 are
knitted into or attached to smart garment 220 in a path that is set
to continuously pass through the continuous section of the garment
between the two unzipped parts of the zipper.
[0188] It should be further noted that the health monitoring and
self-alert system can optionally send the data to any remote
processor, which can further process the information, compare it to
many other monitored people, make statistics-based decisions and
other decision-making methods to improve alerts sensitivity and
specificity and providing information for the treatment of the
living being once getting to a treating facility.
[0189] The invention being thus described in terms of embodiments
and examples, it will be obvious that the same may be varied in
many ways. Such variations are not to be regarded as a departure
from the spirit and scope of the invention, and all such
modifications as would be obvious to one skilled in the art are
intended to be included within the scope of the following
claims.
* * * * *