WEARABLE FETAL MONITORING SYSTEM HAVING
TEXTILE ELECTRODES
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims the benefit under 35 USC 119(e) from US provisional
application 61/830,077 filed June 1st, 2013, the disclosures of which is included herein
by reference.
This application further claims the benefit under 35 USC 119(e) from US
provisional application 62/006,102 filed May 3 1st, 2014, the disclosures of which is
included herein by reference.
This application also related to PCT application PCT/IL2013/050963, filed
November 23, 2013, entitled "Vertical conductive textile traces and methods of knitting
thereof, and PCT application PCT/IL20 13/050964, filed November 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
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
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.
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.
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.
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 noninvasively
(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.
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 noninvasively
from the maternal abdomen have been hampered by the low signal to noise
ratio (S ) 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.
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.
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.
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.
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.
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.
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.
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.
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 personalalert
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
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.
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.
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
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.
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.
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.
Each conductive textile electrode includes a third multiplicity of verticallyaligned
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.
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.
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.
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.
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.
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 (S ) ratio.
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.
Preferably, the maternal and fetal monitoring is performed continuously, day and
night, while performing everyday life chores.
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.
According to further teachings of the present invention, there is provided a
method for maternal and fetal monitoring including the steps of:
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.
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.
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 S than either of the acquired maternal and fetal
electrical vital signals.
d) Analyzing the summed-up mixed signal to thereby extract a maternal signal
from the summed-up mixed signal and maternal-related-parameters thereof.
e) Healing the summed-up mixed signal, including deleting the extracted
maternal signal from the summed-up mixed signal, to thereby form a healedsummed-
up mixed signal.
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.
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.
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.
According to further teachings of the present invention, there is provided a
method for maternal and fetal monitoring including the steps of:
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.
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.
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 S than either of the acquired maternal and fetal
electrical vital signals.
d) Analyzing the summed-up maternal signal to thereby extract a maternal
signal from the summed-up maternal signal.
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.
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.
g) Analyzing the summed-up coherent fetal signal to thereby extract a fetal
signal from the summed-up coherent fetal signal.
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.
The extracting and analyzing of the maternal signal from the summed-up
maternal signal includes:
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.
b) Determining the boundary of each detected maternal QRS complex.
c) Analyzing the summed-up maternal signal to thereby extract the maternal
signal and determine the maternal HR.
d) Analyzing each detected maternal QRS complex to thereby detect health
hazardous data.
The extracting and analyzing of the fetal signal from the summed-up coherent
fetal signal includes:
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.
b) Determining the boundary of each detected maternal QRS complex.
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.
d) Optimally-weighted summing-up the healed-maternal ECG signals to
thereby form a summed-up coherent fetal signal, having a substantially
higher S R than either of the healed-maternal ECG signals.
e) Detecting the peaks of fetal QRS complexes in the summed-up coherent fetal
signal.
f Determining the boundary of each detected fetal QRS complex.
g) Analyzing the summed-up coherent fetal signal to thereby determine the
fetal HR.
h) Analyzing each detected fetal QRS complex to thereby detect health
hazardous data.
The extracting and analyzing of the EMG signal from the summed-up coherent
fetal signal includes:
a) Detecting the peaks in the maternal QRS complexes in the summed-up
maternal signal;
b) Determining the boundary of each detected maternal QRS complex.
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.
Detecting the peaks of the fetal QRS complexes in the summed-up coherent
fetal signal.
e) Determining the boundary of each detected fetal QRS complex.
Deleting each detected fetal QRS complex from the summed-up coherent
fetal signal and filling the gap, thereby forming an EMG summed-up signal.
g) Analyzing the EMG summed-up signal.
The method of filling the gap includes, for example, by linear interpolation or
spline.
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.
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
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:
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.
Fig. 2a is a side view illustration of the underpants shown in Fig. 1, worn by a monitored
pregnant woman.
Fig. 2b is a front view of the underwear monitoring-garment, as shown in Fig 2a.
Fig. 2c is a back view of the underwear monitoring-garment, as shown in Fig 2a.
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.
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.
Fig. 5 is a schematic block diagram of one embodiment of the garment-control device
shown in Figs, 1, 2a and 2b.
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.
Figs. 7a-7d show examples of 4 mixed maternal and fetal electrical signals, each
provided by a respective measuring textile electrode.
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.
Fig. 8 is a schematic flowchart diagram outlining an example method for detecting,
separating and analyzing a maternal QRS signal.
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.
Fig. 10 shows the maternal QRS complexes peaks as detected in the derivative of the
summed-up signal, thereby yielding the maternal heart rate.
Fig. 11 shows the maternal QRS complexes peaks as overlaid over the summed-up
signal.
Fig. 12a shows a magnification of a selected time interval of the summed-up signal, as
shown in Fig. 11.
Fig. 12b shows an example maternal QRS complex that can be medically analyzed.
Fig. 13 is a schematic flowchart diagram outlining an example method for detecting,
separating and analyzing the fetal QRS signals.
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.
Fig. 15 shows the fetal QRS complexes peaks as overlaid over one of the summed-up
coherent fetal signal.
Fig. 16 is a schematic flowchart outlining an example method for detecting and
analyzing an EMG signal.
DETAILED DESCRIPTION OF THE INVENTION
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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 S than either of the acquired mixed electrical
maternal and fetal electrical vital signals.
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).
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.
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.
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.
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.
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 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.
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 remoteprocessor
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.
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.
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 garmentprocessor
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.
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.
As indicated hereinabove, fetal monitoring system 100 of the present invention
preferably includes a mobile device 300, having a remote-processor 310. Remoteprocessor
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.
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.
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.
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.
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.
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.
In variations of the present invention, motion of the fetus within the mother's
uterus, is detected, using multiple ECG electrodes. The S 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.
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.
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.
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.
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 first 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 first 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 first 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:
The maternal and fetal signals are not correlated. Although normally, their HR's
are different, their ranges may be partially overlapping.
• 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.
Typically, with no limitations, over 10 measuring textile electrodes 212 are
used to improve S R, wherein at least 2 measuring textile electrodes 212 are
disposed proximal to the heart of the fetus.
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.
Method 600 includes the following steps:
Step 610: acquiring N signals as sensed by respective N selected measuring textile
electrodes 212.
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.
Step 620: filtering the acquired signals.
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: , a derivative signal that contains the QRS complexes peaks
data; and , representing the filtered signal.
Step 630: detecting derivative peaks.
Using the derivative signal y , garment-control device 110 detects derivative
peaks that correspond to the maternal QRS complexes peaks of the respective
sensed mixed ECG raw signal.
Step 640: Optimally aligning the respective peaks of the N signals.
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.
To improve phase alignment process an analytical (complex) signal, such as
Hilbert transform, may be used.
Step 650: summing-up the N signals.
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.
Step 660: determining the boundary of maternal QRS complexes.
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.
Step 670: analyzing the maternal QRS complexes.
Garment-control device 110 analyzes, for example by performing a
morphologically analysis, and to determine the maternal HR and possibly detect
health hazardous data.
{end of steps details of process 600}
Example
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.
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.
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.
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
{end of example}
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.
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.
Hence, after steps 610-660 of method 600 are performed, method 700 proceeds
with the following steps:
Step 710: healing the N filtered ECG signals.
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.
Step 720: filtering the acquired signals.
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 healedmaternal
ECG signal yields to signals: 2, derivative signal that contains the
QRS complexes peaks data; and y , representing the filtered signal.
Step 730: detecting derivative peaks.
Using the derivative signal y 2 , garment-control device 110 detects derivative
peaks that correspond to the fetal QRS complexes peaks of the respective healedmaternal
ECG signal .
Step 740: Optimally aligning the respective peaks of the N signals.
Garment-control device 110 reads all filtered healed mixed signals y and
respective derivative healed signals , 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.
To improve phase alignment process an analytical (complex) signal, such as
Hilbert transform, may be used.
Step 750: summing-up the N signals.
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 S R than either of the healed-maternal ECG signal.
Step 760: determining the boundary of fetal QRS complexes.
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.
Step 770: analyzing the fetal QRS complexes.
Garment-control device 110 analyzes, for example by performing a
morphologically analysis, and to determine the fetal HR and possibly detect
health hazardous data.
{end of steps details of process 700}
Example
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.
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
{end of example}
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:
Step 810: healing the summed-up coherent fetal signal.
Garment-control device 110 deletes the fetal QRS complexes from the summedup
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.
Step 820: analyzing the EMG signal.
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.
(end of steps details of process 800)
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.
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.
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.
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.
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.
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.

WHAT IS CLAIMED IS:
1. A smart maternal monitoring garment comprising:
a) a tubular form having variable elasticity, said tubular form having a first
multiplicity of knitted or interwoven lines, wherein each said line is knitted or
interwoven with at least one non-conductive yarn; and
b) a second multiplicity of conductive textile electrodes for sensing maternal and fetal
electrical vital signals, each said conductive textile electrode having:
i . a third multiplicity of vertically-aligned line segments, wherein each said
segment is formed within said knitted or interwoven lines with a nonconductive
yarn and a conductive yarn; and
ii. a skin-side face configured to electrically conduct said signal from a
predetermined external surface region of a pregnant woman,
wherein each said conductive textile electrode is adapted to be in communication flow with
a processor.
2 . The maternal garment of claim 1, wherein said 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.
3 . The maternal garment of claim 1, wherein said predetermined external surface region
is selected from a group including the abdomen, the perineum and buttocks of said pregnant
woman.
4 . The maternal garment of claim 1, wherein said second multiplicity of conductive
textile electrodes includes a preconfigured number of measuring electrodes and a
preconfigured number of reference electrodes.
5 . The maternal garment of claim 4, wherein each said measuring electrode is paired
with at least one reference electrode.
6 . The maternal garment of claim 4, wherein each given said conductive textile
electrode, in a specific measurement instance, is paired with a preconfigured number of
other said conductive textile electrodes, and wherein in each said pairing, said given
conductive textile electrode serves either as a measuring electrode or as a reference
electrode, thereby facilitating increasing the number of differential measurements acquired,
in said specific measurement instance, beyond said second multiplicity of said conductive
textile electrodes.
7 . The maternal garment of claim 4, wherein said measuring electrodes and said
reference electrodes are positioned, within the maternal garment, in preconfigured locations.
8 . The maternal garment of claim 7, wherein said position of said measuring electrodes
and said reference electrodes are preconfigured to thereby optimize the spatial coverage of
the uterine.
9 . The maternal garment of claim 4, wherein the pairing of said measuring electrodes
and respective said reference electrodes is preset using said processor.
10. The maternal garment of claim 9, wherein said number of measuring electrodes, said
number of reference electrodes and said pairing thereof are preset to thereby optimize the
signal to noise (S ) ratio.
11. The maternal garment of claim 1, wherein said 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 said designated knitting or interweaving density of
said tubular form, thereby providing said variable elasticity, to enable stable conductive
contact of said skin-side face of each said electrode with the skin of said pregnant woman.
12. The maternal garment of claim 1, wherein said maternal and fetal monitoring is
performed continuously, day and night, while performing everyday life chores.
13. The maternal garment of claim 1, wherein said processor is adapted to alert at least
one preconfigured receiving entity, upon detecting a health hazard.
14. The maternal garment of claim 1, wherein said conductive textile electrode are in
communication flow with the processor via conductive stripes or line traces; wherein the
tubular form further includes a generally vertical zipper; and wherein said conductive stripes
or line traces are attached to or knitted into said smart garment in a path that is set to
continuously pass through the continuous section of the garment between the two unzipped
parts of said zipper.
15. The maternal garment of claim 13, wherein said preconfigured receiving entity is
selected from the group including a smart personal electronic device of said pregnant
woman, a smart personal electronic device of another person, a medical personal, and a
computerized center.
16. 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 S 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.
17. The method of claim 16, 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.
18. The method of claim 16, 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.
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 maternal signal, having a substantially
higher S than either of the acquired maternal and fetal electrical vital signals;
d) analyzing the summed-up maternal signal to thereby extract the maternal signal
from said summed-up maternal signal; and
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;
f) optimally weighted summing-up said 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;
g) analyzing said summed-up coherent fetal signal to thereby extract a fetal signal
from said summed-up coherent fetal signal.
20. The method of claim 19 further comprising the step of:
h) analyzing said summed-up coherent fetal signal thereby extract the EMG signal
formed by electromyogram (EMG) activities including uterine activities, from said
summed-up coherent fetal signal.
21. The method of claim 19, wherein said extracting and analyzing of said maternal signal
from said summed-up electrical signal comprises the steps of:
a) detecting the peaks in the maternal QRS complexes using said summed-up
maternal signal, the maternal QRS complexes peaks being substantially stronger
than the fetal QRS complexes;
b) determining the boundary of each said detected maternal QRS complex;
c) analyzing said summed-up maternal signal to thereby extract said maternal signal
and determine the maternal HR; and
d) analyzing each said detected maternal QRS complex to thereby detect health
hazardous data.
22. The method of claim 19, wherein said extracting and analyzing of said fetal signal
from said summed-up electrical signal comprises the steps of:
a) detecting the peaks in the maternal QRS complexes in said summed-up maternal
signal, the maternal QRS complexes peaks being substantially stronger than the
fetal QRS complexes;
b) determining the boundary of each said detected maternal QRS complex;
c) deleting each said detected maternal QRS complex from the respective said
acquired mixed maternal and fetal electrical vital signal and filling the gap, thereby
forming a respective healed-maternal ECG signal;
d) optimally -weighted summing-up said healed-maternal ECG signals to thereby form
a summed-up coherent fetal signal, having a substantially higher S R than either
of said healed-maternal ECG signals;
e) detecting the peaks of fetal QRS complexes in said summed-up coherent fetal
signal;
f) determining the boundary of each said detected fetal QRS complex;
g) analyzing said summed-up maternal signal to thereby extract said fetal signal and
determine the fetal HR; and
h) analyzing each said detected fetal QRS complex to thereby detect health hazardous
data.
23. The method of claim 20, wherein said extracting and analyzing of said EMG signal
from said summed-up electrical signal comprises the steps of:
a) detecting the peaks in the maternal QRS complexes in said summed-up maternal
signal;
b) determining the boundary of each said detected maternal QRS complex;
c) deleting each said 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;
d) detecting the peaks of fetal QRS complexes in said summed-up coherent fetal
signal;
e) determining the boundary of each said detected fetal QRS complex;
f) deleting each said detected fetal QRS complex from the summed-up coherent fetal
signal and filling the gap, thereby forming a EMG summed-up signal; and
g) analyzing the EMG summed-up signal.
24. The method of claims 22 and 23, wherein said filling of said gap includes by using
linear interpolation or spline.
25. The method of claim 23, wherein said analysis of said EMG summed-up signal
includes performing a morphologically analysis to thereby determine if the uterine is
contracting at a rate and amplitude that requires hospitalization for birth giving.
26. The method of claim 22, wherein said summed-up coherent fetal signal contains more
than one fetus and wherein said 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.
27. The method of claim 26, wherein said separation of the signal of each fetus is
performed using Fourier transform.
28. The method of claim 19, wherein said maternal garment is worn without attaching
either of said electrodes,
regardless of the precise bodily positioning of each said electrode;
regardless of the chronological stage of the pregnancy; and
regardless of the amount of stretching of the tubular form and of each said electrode.
29. The method of claim 19, wherein said maternal signal includes maternal heart rate.
30. The method of claim 19, wherein said fetal signal includes fetal heart rate.
31. The method of claim 19, wherein said predetermined external surface region is
selected from a group including the abdomen, the perineum and buttocks of said pregnant
woman.
32. The method of claim 19, wherein said conductive textile electrodes include a
preconfigured number of measuring electrodes and a preconfigured number of reference
electrodes.
33. The maternal garment of claim 32, wherein each said measuring electrode is paired
with at least one reference electrode.
34. The method of claim 32, wherein each given said conductive textile electrode, in a
specific measurement instance, is paired with a preconfigured number of other said
conductive textile electrodes, and wherein in each said pairing, said given conductive textile
electrode serves either as a measuring electrode or as a reference electrode, thereby
facilitating increasing the number of differential measurements acquired, in said specific
measurement instance, beyond said second multiplicity of said conductive textile electrodes.
35. The method of claim 32, wherein said measuring electrodes and said reference
electrodes are positioned, within the maternal garment, in preconfigured locations.
36. The method of claim 35, wherein said position of said measuring electrodes and said
reference electrodes are preconfigured to thereby optimize the spatial coverage of the
uterine.
37. The method of claim 32, wherein the pairing of said measuring electrodes and
respective said reference electrodes are preset using said processor.
38. The method of claim 37, wherein said number of measuring electrodes, said number
of reference electrodes and said pairing thereof are preset to thereby optimize the signal to
noise (S ) ratio.