U.S. patent number 3,811,428 [Application Number 05/214,287] was granted by the patent office on 1974-05-21 for biological signals monitor.
This patent grant is currently assigned to Brattle Instrument Corporation. Invention is credited to Paul Epstein, Patrick G. Phillipps, Joseph M. VanHorn.
United States Patent |
3,811,428 |
VanHorn , et al. |
May 21, 1974 |
**Please see images for:
( Certificate of Correction ) ** |
BIOLOGICAL SIGNALS MONITOR
Abstract
Biological signals (especially, e.g., fetal QRS complexes) are
monitored with signal processing circuitry featuring, in various
aspects, in the fetal heart rate monitor, automatic thresholding of
maternal and fetal signals; a digital phase lock loop for
generating fetal heart rate signals related to the loop frequency,
the loop including means for estimating the rate during occurrences
of blank spaces caused by removal of signals representing merged
maternal and fetal heart beats; counter controlled means for
disabling readout; low impedance preamplification of signals
received from the body; and a low Q filter with significant useful
output energy in the 50-100Hz range, 60Hz noise being removed by a
notch filter.
Inventors: |
VanHorn; Joseph M. (Cambridge,
MA), Epstein; Paul (Brookline, MA), Phillipps; Patrick
G. (Framingham, MA) |
Assignee: |
Brattle Instrument Corporation
(Cambridge, MA)
|
Family
ID: |
22798512 |
Appl.
No.: |
05/214,287 |
Filed: |
December 30, 1971 |
Current U.S.
Class: |
600/511 |
Current CPC
Class: |
A61B
5/344 (20210101); A61B 5/4362 (20130101) |
Current International
Class: |
A61B
5/0444 (20060101); A61B 5/0402 (20060101); A61b
005/04 () |
Field of
Search: |
;128/2.5P,2.5R,2.5S,2.5T,2.6A,2.6P,2.6E,2.6R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,445,220 |
|
May 1966 |
|
FR |
|
975,373 |
|
Nov 1964 |
|
GB |
|
Primary Examiner: Kamm; William E.
Claims
We claim:
1. In a fetal heart rate monitor having a pickup for electrical
signals received through the body of the mother, and means for
providing an output relating to fetal heart rate,
input circuitry means defining a signal processing path and
responsive to said pickup for producing along said path a signal
train including first signals representing maternal heart beats and
second signals representing fetal heart beats, some of said first
signals also representing fetal heart beats which occurred
simultaneously with maternal heartbeats,
removal means for removing from said path at least the major
portions of said first signals, whereby blank spaces are left by
such removal of those of said first signals representing fetal
heart beats which occurred simultaneously with maternal heart beats
and
circuitry means defining a phase lock loop having a frequency and
including means responsive to the thus modified train of signals
for generating fetal heart rate signals related to said frequency,
said phase lock loop including means responsive to the spacing
characteristics between said signals in said modified train for
estimating fetal heart rate during the occurrence of said blank
spaces in said modified train,
said circuitry means defining said phase lock loop including means
for producing repeating windows spaced to overlap a fetal signal on
the basis of past spacing statistics despite variation within
predetermined limits, said circuitry means further including
updating means for detecting the position of successive fetal
signals within the respective windows and for varying future
windows spacing on the basis of the detected position of the
signals in the windows.
2. The fetal heart rate monitor of claim 1 wherein means are
provided for producing, at said phase lock loop, a train of digital
signals, each representing a fetal QRS complex, including means for
disabling said updating means upon the occurrence of no pulse or
more than one pulse in said window, thereby continuing the use of
the past spacing setting.
3. The fetal heart rate monitor of claim 2 wherein said updating
means includes means to relocate the next window upon the
occurrence of a single pulse in the present window by pulse shift
of the past spacing in the event no single pulse appeared in the
last preceding window.
4. The fetal heart rate monitor of claim 2 wherein said updating
means includes means to relocate the next window upon the
occurrence of a single pulse in the present window by alteration of
the loop frequency in the event a single pulse appeared in the last
preceding window.
5. The fetal heart rate monitor of claim 2 wherein said updating
means includes means to relocate the next window upon the
occurrence of single pulses in two successive windows by alteration
of the loop frequency so that the corresponding altered window
period is between the window period prior to said alteration and
the spacing between said two single pulses.
6. The fetal heart rate monitor of claim 1 including a counter,
means for incrementing said counter upon the occurrence of signals
outside said window and means for decrementing said counter upon
the occurrence of signals inside said window, including means for
weighing more heavily in said count the signals outside said window
and means for resetting said phase lock loop upon the occurrence of
a count greater than a predetermined value.
7. The fetal heart rate monitor of claim 1 further comprising
circuitry means defining a second signal processing path and for
transmitting along said second path third signals representing
maternal heart beats, said removal means having a connection to
said circuitry means defining said second path and being responsive
to occurrence of said third signals in said second path.
8. The fetal heart rate monitor of claim 7 including in said
circuitry means defining said second path, preceding said
connection, an automatic threshold means for generating from a
signal derived from a maternal QRS complex a signal representative
thereof.
9. The fetal heart rate monitor of claim 8 including as said
threshold means a peak detector including means for fixing
predetermined limit and for storing a value less than said limit
and allowing said stored value to decay over time, and a comparator
effectively connected to said peak detector and to said circuit
means defining said second path for generating an output signal
when a signal in said second path exceeds the decayed value of the
preceding peak stored in said detector.
10. The fetal heart monitor of claim 9 including a monostable
multivibrator effectively connected to said comparator foor
energization upon the occurrence of said output signal, said
monostable multi-vibrator having a time constant substantially
corresponding to the maximum width of the maternal QRS complex.
11. The fetal heart rate monitor of claim 7 wherein there is
included in said circuitry means defining said first path an
automatic threshold means for generating from a fetal QRS complex
wave a signal representative thereof.
12. The fetal heart rate monitor of claim 11 including as said
threshold means a peak detector including means for fixing a
predetermined limit and for storing a value greater than said limit
and allowing said stored value to decay over time, and a comparator
effectively connected to said peak detector and to said circuitry
defining said first path for generating an output signal when a
signal exceeds the decayed value of the preceding peak stored in
said detector.
13. The fetal heart rate monitor of claim 12 including means in
said first path effectively connected to said comparator and
responsive to signals in said second path for removing output
signals from said comparator which coincide in time with a maternal
QRS complex, thereby to remove portions of maternal signals present
in the output of said comparator.
14. The monitor of claim 1 wherein said phase lock loop is
digital.
15. In a monitor having a pickup for a first electrical signal
representing a first component of a recurring complex biological
signal including a second component that is stronger than the first
component, and output circuitry means including means for providing
an output related to occurrences of said first component,
circuitry means defining a signal processing path in which said
first signals are detected and along part of which second signals
representing occurrences of said second component are transmitted,
and
automatic thresholding means in said path for tracking the
magnitude of signals other than said second signals and providing
an output to said output circuitry means signifying the occurrence
of said first component only upon receipt of a signal other than a
said second signal and of magnitude bearing a predetermined
relationship to the magnitude of the next previously tracked signal
but being independent of signals tracked prior to said next
previously tracked signal.
16. The monitor of claim 15 further comprising circuitry means
defining a second signal processing path and for transmitting
therealong, in timed relationship to said transmission of said
second signals along said first path, third signals representing
said occurrences of said second component, and means for detecting
said third signals and, in response to said detection, for
preventing effective response by said automatic thresholding means
to said second signals.
17. The monitor of claim 16 for use in monitoring the rate of fetal
heartbeats, wherein said pickup includes a plurality of electrodes
for placement on the mother in separate positions respectively
optimizing the pickup of maternal and fetal QRS complex signals,
and said circuitry means defining said paths includes separate
preamplification means effectively connected to said electrodes for
respectively receiving and amplifying said maternal and fetal
signals, whereby said first and second signal paths are separate at
their front ends.
18. The monitor of claim 16 wherein said second path includes
automatic thresholding means for tracking signal magnitude and
providing an output to said automatic thresholding means in said
first path signifying the occurrence of said second component only
upon receipt of a signal of magnitude bearing a predetermined
relationship to previously tracked signal magnitude.
19. The monitor of claim 15 wherein said automatic thresholding
means includes
means for storing and decaying over time the peak value of a
received signal, and
a comparator effectively connected to said means for storing, said
comparator including means for providing said output when a
received signal is greater than a predetermined percentage of the
decayed value presently stored.
20. The monitor of claim 19 wherein means are provided for fixing
said predetermined percentage at 70-90 percent.
21. The monitor of claim 19 wherein said means for storing includes
means for preventing the value stored therein from decaying below a
limit, including means for establishing said limit.
22. The monitor of claim 21 wherein said means for establishing
said limit includes means for monitoring the past history of
signals reaching said automatic thresholding means and for varying
said limit in accordance with said history.
23. The monitor of claim 21 wherein said means for establishing
said limit includes means for fixing said limit.
24. The monitor of claim 15 further comprising
removal means for removing at least the major portions of said
second signals from said path, while leaving leading edges of said
second signals,
delay means for receiving signals from said removal circuitry,
including signals representing said leading edges, and
means for excluding from the effective output of said delay means
said signals representing said leading edges.
25. The monitor of claim 24 further comprising means for detecting
the falling edges of said first signals and for causing said output
of said delay means to be responsive to the occurrences of said
falling edges.
26. In a fetal heart rate monitor, electrode means for picking up
electrical signals corresponding to fetal QRS complex signals,
signal processing circuitry means effectively connected to said
electrode means and including
a pre-amplifier for receiving said electrical signals from said
electrode means,
a filter for the amplified signals, said filter having Q less than
10 and including means to provide an output in which at least 25
percent of the signal energy is in the 50-100 Hz range, exclusive
of line frequency noise, and
a notch filter for removing said line frequency noise, and
means effectively connected to said signal processing circuitry for
providing an output relating to fetal heart rate.
27. The monitor of claim 26 comprising automatic thresholding means
effectively connected between said filters and said readout for
tracking signal magnitude and providing an output signalling the
occurrence of a fetal QRS complex only upon receipt of a signal of
magnitude bearing a predetermined relationship to previously
tracked signal magnitude, said thresholding means including means
for determining said relationship.
28. The monitor of claim 27 further comprising additional signal
processing means for electrical signals corresponding to maternal
QRS complex signals, and means connected in the signal path leading
to said automatic thresholding means for preventing at least the
major portion of electrical signals corresponding to maternal QRS
complex signals from reaching said automatic thresholding means,
said means for preventing being responsive to detection of said
electrical signals processed by said additional signal processing
means.
29. The monitor of claim 26 wherein said processing circuitry from
said electrode means through said filter includes means to provide
linear processing of input signals.
30. In a fetal heart rate monitor having a pickup for electrical
signals received through the body of the mother, and output
circuitry means including means for providing an output relating to
fetal heart rate,
input circuitry means defining a signal processing path and
responsive to said pickup for producing along said path a signal
train including first signals representing maternal heart beats and
second signals representing fetal heart beats, some of said first
signals also representing fetal heart beats which occurred
simultaneously with maternal heart beats,
removal means for removing from said path at least the major
portions of said first signals, whereby blank spaces are left by
such removal of those of said first signals representing fetal
heart beats which occurred simultaneously with maternal heart
beats,
circuitry means defining a phase lock loop having a frequency and
including means responsive to the thus modified train of signals
for generating and providing to said output circuitry means fetal
heart rate signals related to said frequency, said phase lock loop
including means responsive to the spacing characteristics between
said signals in said modified train for estimating fetal heart rate
during the occurrence of said blank spaces in said modified train,
and
circuitry means defining a second signal processing path and for
transmitting along said second path third signals representing
maternal heart beats, said removal means having a connection to
said circuitry means defining said second path and being responsive
to occurrence of said third signals in said second path,
said circuitry means defining said second path including, preceding
said connection, input means for a maternal QRS complex signal, a
notch filter for removing line frequency noise, and a band pass
filter having Q less than 10 and a center frequency between 15 Hz
and 25 Hz.
31. In a fetal heart rate monitor having a pickup for electrical
signals received through the body of the mother, and output
circuitry means including means for providing an output relating to
fetal heart rate,
input circuitry means defining a signal processing path and
responsive to said pickup for producing along said path a signal
train including first signals representing maternal heart beats and
second signals representing fetal heart beats, some of said first
signals also representing fetal heart beats which occurred
simultaneously with maternal heart beats,
removal means for removing from said path at least the major
portions of said first signals, whereby blank spaces are left by
such removal of those of said first signals representing fetal
heart beats which occurred simultaneously with maternal heart
beats,
circuitry means defining a phase lock loop having a frequency and
including means responsive to the thus modified train of signals
for generating and providing to said output circuitry means fetal
heart rate signals related to said frequency, said phase lock loop
including means responsive to the spacing characteristics between
said signals in said modified train for estimating fetal heart rate
during the occurrence of said blank spaces in said modified train,
and
circuitry means defining a second signal processing path and for
transmitting along said second path third signals representing
maternal heart beats, said removal means having a connection to
said circuitry means defining said second path and being responsive
to occurrence of said third signals in said second path,
said circuitry means defining said first path including, preceding
said connection, input means for a fetal QRS complex signal, a
notch filter for removing line frequency noise, and a band pass
filter having Q less than 10 and a center frequency between 25 Hz
and 40 Hz.
32. In a fetal heart rate monitor having a pickup for signals
emanating from the fetus,
input circuitry means responsive to said pickup for producing a
signal train including signals representing fetal heart beats,
prediction circuitry means responsive to said input circuitry for
predicting occurrences of said signals representing fetal heart
beats, based upon past occurrences of such signals in said train,
and
output circuitry means responsive of said input and prediction
circuitry means for providing an output relating to fetal heart
rate, said output circuitry means including means for basing said
output on said signals representing fetal heart beats when such
signals occur within a predetermined range of predicted occurrences
thereof and for otherwise basing said output on said predicted
occurrences,
said prediction circuitry means including means for basing said
predictions at least in part upon selected previous predictions
upon which said output was based.
33. The improvement of claim 32 wherein said prediction circuitry
means includes means for referring the phase of a said predicted
occurrence to the next previous said predicted occurrence if said
output was based thereupon, and otherwise to the next previous said
signal representing a fetal heart beat upon which said output was
based.
34. The improvement of claim 32 wherein said output circuitry
includes means for basing said output upon a said predicted
occurrence whenever more than one pulse in said signal train occurs
within said predetermined range of said predicted occurrence.
35. In a monitor having a pickup for a first electrical signal
representing a first component of a recurring complex biological
signal including a second component that is stronger than the first
component,
input circuitry means responsive to said pickup for producing a
signal train including signals representing occurrences of said
first component,
prediction circuitry means responsive to said input circuitry for
predicting occurrences of said signals representing occurrences of
said first component, based upon past occurrences of such signals
in said train, and
output circuitry means responsive to said input and prediction
circuitry means for providing an output related to occurrences of
said first component, said output circuitry means including means
for basing said output on said signals representing occurrences of
said first component when said signals occur within a predetermined
range of predicted occurrences thereof and for otherwise basing
said output on said predicted occurrences,
said prediction circuitry means including means for basing said
predictions at least in part upon selected previous predictions
upon which said output was based.
36. In a fetal heart rate monitor having a pickup for signals
emanating from the fetus,
input circuitry means responsive to said pickup for producing a
signal train including signals representing fetal heart beats with
attendant noise signals and with some heart beats unrepresented in
the signal train,
prediction circuitry means responsive to said input circuitry for
predicting occurrences of said signals representing fetal heart
beats, based upon past occurrences of such signals in said train,
and
output circuitry means responsive to said input and prediction
circuitry means for providing an output relating to fetal heart
rate,
said prediction circuitry means including means for repeatedly
producing a window overlapping the predictable point in time of the
next heart beat based upon past occurrences, said output circuitry
means responsive to a signal occurring in a window to treat said
signal as a detected heart beat and agjust the output according to
the position of the signal in the signal train, said output
circuitry means further including means for disregarding as noise
any signals occurring outside of said window, means causing said
prediction circuitry to continue to operate when a heart beat is
not detected in a window to produce a window for the next
succeeding heart beat, said window having a duration sized to
overlap a fetal heart beat signal in the presence of a
predetermined amount of predicted change in fetal heart rate which
may occur over a plurality of heart beat intervals.
37. The monitor of claim 36 wherein said output circuitry includes
means for disregarding as noise occurrences of multiple signals in
a single window.
38. The monitor of claim 36 wherein the duration of each said
window is approximately one half of a predicted fetal heart beat
interval.
39. The monitor of claim 38 wherein said prediction circuitry
establishes the duration of said windows based upon the duration of
the currently predicted heart beat interval.
40. In a monitor having input circuitry means including a pickup
for a train of signals, including true and false signals,
representative of a selected component of quasi-periodic, complex
physiological electrical signals, signal-to-signal spacing being
variable, and output circuitry means including means for providing
an output relating to real and expected occurrences of said
component:
means for receiving said train of signals from said input circuitry
means;
window means responsive to said input circuitry means for producing
windows spaced in accordance with the previous history of said
train of signals for enabling said receiving means to effectively
receive said signals only during an interval prescribed by each
said window; and
output means coupled to said receiving means and window means for
producing and providing to said output circuitry output signals
indicative of real and expected occurrences of true quasi-periodic
signals occurring in said train.
41. The monitor of claim 40, further comprising:
quality means responsive to said input circuitry means and said
window means for providing a quality signal indicative of the
occurrence of true signals relative to false signals from said
train of signals; and
control means responsive to said quality means for controlling the
operation of said window means in accordance with said quality
signal.
42. The monitor of claim 41, wherein:
said quality means includes counter means for counting signals
occurring between said windows; and
said control means operates to reset said window means to its
initial condition in the event the number of such counts exceeds a
predetermined magnitude.
43. In a monitor having input circuitry means including a pickup
for recurrent complex electrical physiological signals having a
first component weaker than a second component and in the presence
of extraneous recurrent noise signals, and output circuitry means
including means for providing an output relating to occurrences of
said first component, processing circuitry means coupled to said
input and output circuitry means and comprising:
band pass filter means having a Q under 10 for passing signals
having a frequency content spanning the maximum energy in said
first component;
notch filter means for excluding extraneous noise of a selected
frequency; and
automatic threshold means responsive to said filtered first
component for excluding signals below a threshold determined as a
function of previously received filtered first component signals to
produce and provide to said output circuitry means a train of
signals representative of said first component.
44. In a monitor having a pickup for electrical signals
representing occurrences of at least a component of a recurring
complex biological signal,
input circuitry means responsive to said pickup for producing a
signal train including said signals representing said
occurrences,
prediction circuitry means responsive to said input circuitry means
for making predictions of said occurrences based upon past history
of said signals in said train,
output circuitry means responsive to said input and prediction
circuitry means for providing an output relating to occurrences of
said component, including elements for basing said output upon said
predictions under predetermined circumstances,
quality circuitry means for determining deviation of said signals
from said predictions and thereby evaluating the reliability of
said output, and
restart circuitry means for reinitiating derivation of said
predictions when said quality means indicates a predetermined
degree of unreliability.
45. In the monitor of claim 44, output disabling means for
preventing output when said quality means indicates a predetermined
degree of unreliability, including means for requiring a higher
reliability to permit output during said reinitiation than when
said reinitiation is completed.
46. The monitor of claim 44 wherein the restart circuitry means
includes means for requiring a higher degree of reliability for
acceptance of an attempted reinitiation than the reliability
required when said reinitiation is completed.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to monitoring biological signals, and is
particularly applicable to the measurement of fetal heart rate.
2. Description of the Prior Art
It is known that the patterns of change in fetal heart rate during
labor contain information about the well-being of the fetus. Thus,
efforts have been made to accurately measure fetal heart rate. Some
of these efforts have employed direct acoustical pickup. Others
have relied upon the doppler shift in an ultrasonic signal
reflected from the moving wall of the fetal heart. Still others
detect electrical signals, either directly from the fetal scalp, or
through the maternal abdomen. Abdominal detection is complicated by
the masking effect of the maternal heartbeat, which is many times
stronger than, and frequently merges (i.e., occurs simultaneously)
with, the fetal, and by a variety of other sources of noise that
make accurate detection of the very weak fetal signals extremely
difficult; existing devices for abdominal detection are difficult
to operate and are not reliably accurate.
SUMMARY OF THE INVENTION
The invention makes possible real time monitoring of fetal heart
rate (as well as analogous monitoring of other relatively weak
components of complex biological signals, such as T and P waves in
ECG signals) with improved accuracy and reliability, yet with
equipment that is relatively inexpensive and easy to operate. The
system is operable over a wide range of frequencies; excellent
electrical isolation of the patient is provided; and excellent
balance is achieved between avoiding readout of erroneous
information and minimizing readout outages during which accurate
information is lost (including, e.g., rapid recovery from outages
caused by noise).
In general the invention features, in one aspect, a monitor for a
first electrical signal representing a first component of a
recurring complex biological signal including a second component
that is stronger than the first component (the components
respectively being fetal and maternal QRS complexes when the
invention is embodied in a fetal heart rate monitor), the monitor
comprising a signal processing path in which the first signals are
detected and along part of which second signals representing
occurrences of the second component are transmitted, automatic
thresholding circuitry in the path for tracking signal magnitude
and providing an output signifying the occurrence of the first
component only upon receipt of a signal of magnitude bearing a
predetermined relationship to previously tracked signal magnitude,
and means for preventing effective response by the automatic
thresholding circuitry to the second signals. In its several other
aspects the invention, in general, features logic circuitry for
generating readout signals, with the decision as to each readout
signal being based in part upon a statistical prediction derived
from the pattern of signals received in past time periods,
including (in the fetal heart rate monitor) a phase lock loop for
generating fetal heart rate signals related to the loop frequency,
the loop including means for estimating the rate during the
occurrences of blank spaces in the modified signal train caused by
removal of signals representing merged maternal and fetal heart
beats; a counter responsive to deviation between the time of signal
receipt by the logic circuitry and the prediction thereof, the
counter increasing upon an instance of deviation greater than a
predetermined value, readout being disabled when the counter is
above a first count, derivation of the prediction being reinitiated
when the counter reaches a second, higher count; electrodes for
picking up the signals from a human body, and a low impedance
pre-amplifier followed by a high impedance isolation amplifier
magnetically (or otherwise indirectly) coupled at its output to the
rest of the signal processing circuitry; a delay for receiving
signals including fragments of incompletely removed second
(maternal) signals, and means for excluding those fragments from
the effective output of the delay; and a low Q filter for linearly
processed signals corresponding to fetal QRS complexes, the filter
output having at least 25 percent of its signal energy in the
50-100Hz range (exclusive of 60Hz noise), and a notch filter for
removing 60Hz noise. In preferred embodiments the invention
features a digital phase lock loop adapted to produce repeating
windows each sized and spaced to overlap a fetal signal on the
basis of past spacing statistics despite variation within
predetermined limits; means for updating under certain conditions
the phase and frequency of the windows on the basis of the actual
positions of the signals within the windows; a separate electrode
for picking up maternal QRS complex signals, with signal processing
circuitry which the maternal signals are transmitted in timed
relationship to the transmission of maternal signals over the first
path, the circuitry having a connection to the first path for the
removal of maternal signals therefrom; and automatic thresholding
means for both maternal and fetal signals, the fetal signal
thresholding means including means for storing and decaying peak
signal values, between an upper limit and a variable lower limit
responsive to average signal value over the recent past.
Other advantages and features of the invention will be apparent
from the description and drawings herein of a preferred embodiment
thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a block diagram of the analog signal processing
circuitry;
FIGS. 2a, b together comprise a circuit diagram corresponding to
FIG. 1;
FIGS. 3-8 comprise voltage-time graphs illustrating the signal
patterns at various stages of the circuitry of FIGS. 1, 2a, and
2b;
FIG. 9 is a flow chart of the digital phase lock loop and readout
algorithm;
FIG. 10 is a block diagram of the digital phase lock loop and
readout circuitry for implementing the algorithm illustrated in
FIG. 9.
FIGS. 11a, b, c, d together comprise a circuit diagram
corresponding to FIG. 10.
FIGS. 12 and 13 comprise circuit diagrams of timing pulse
generators; and
FIG. 14 is a combined block and circuit diagram illustrating
variable lower limit circuitry for the fetal signal peak
detector.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1, electrodes 10 and 11 are provided for
placement on the patient to pick up the maternal and fetal QRS
signals and feed them through ultra-low noise gain of 30 amplifiers
12 and 13 to patient isolation amplifiers 16 and 18, respectively.
Electrode 11 is placed on the abdomen, where the best fetal signal
is available, and electrode 10 preferably in position (e.g., on the
ribs) to maximize the maternal signal. Reference electrode 20 is
placed on the hip.
Amplifiers 12 and 13 have a low impedance, of the order of 10.sup.5
ohms. As shown in the detailed circuitry of FIGS. 2a-, these
amplifiers are shunted by 100K resistors and 0.01.mu.f capacitors.
It has been discovered that such low impedance gives an improvement
in signal-to-noise ratio which outweighs the corresponding
reduction in overall signal level. Amplifiers 16 and 18 are
transformer coupled to the rest of the system and to their power
supply, and provide a very high impedance (of the order of
10.sup.12 ohms) between the electrodes and ground, thus protecting
the patient from shock.
The amplified maternal signal passes through a low Q (less than 10,
and preferably 1/2 to 1) band pass active filter 28 centered at
17Hz (the optimum in a preferred center frequency range of
15-25Hz), the center of peak energy in the maternal QRS waves. The
amplified fetal signal is passed through a cascaded pair of
similarly low Q band pass active filters 30, 32 centered at 32Hz
(the optimum in a preferred range of 25-40Hz for center frequency),
the center of peak energy in the fetal QRS waves, thay energy
extending roughly from 5Hz to 100Hz. (In the detailed circuitry of
FIG. 2, filters 28 and 30 are incorporated into amplifiers 16 and
18, which respectively provide gains of 20 and 40 with Q = 1.)
These low Q filters provide excellent transient response
(equivalent to that of matched filters) to the thus far linearly
processed signals they receive. The filtering characteristics of
the cascaded pair of filters 30, 32 multiply, narrowing the
bandwidth and providing a very flat characteristic. The output of
filter 32 has at least 25 percent of the signal energy in the
50-100Hz range (exclusive of 60Hz noise), since important useful
energy of the fetal waves lies there. By thus increasing the
effective utilization of the fetal wave energy, and dealing
separately later with the accompanying 60Hz noise, improved
signal-to-noise ratio is ultimately achieved.
The signals from filters 28 and 30 fed voltage controlled
oscillators 29 and 31 which convert the input voltage into a
frequency which bears a linear relationship to the input voltage,
in effect generating an FM signal of th input wave form. The output
voltages from the oscillators pass through isolation transformers
which are coupled into demodulating and analog circuitry including
analog phase lock loops 33 and 35 which convert the signal back
into a wave form identical with that which was fed into the voltage
controlled oscillators.
After further amplification of the maternal signal in amplifier 34,
the maternal and fetal signals pass through 60Hz twin T notch
filters 36, 38 for attenuation of 60Hz noise, and are fed to
precision full wave rectifiers 40 and 42, respectively. FIG. 3
illustrates the maternal and fetal waveforms 44 and 46 (waveform 46
of course still including maternal as well as fetal signals),
respectively, at the rectifier inputs, and the corresponding
outputs 48 and 50. The rectifiers eliminate any need to consider
varying signal polarity.
Considering now the maternal signal, the output of rectifier 40 is
fed both to peak detector 52 and comparator 54. The peak detector
stores and gradually decays toward zero the value of peak amplitude
of a signal reaching it, until it receives another signal having a
peak amplitude higher than the instantaneous value to which the
originally stored peak has decayed; the new peak value is thus
stored, and so on. The second input to comparator 54 is 90 percent
(the preferred range is 70-90 percent) of the value stored in the
peak detector. The comparator fires whenever the output of
rectifier 40 has a peak greater than 90 percent the value stored in
the peak detector. In effect, then, automatic thresholding of the
maternal signal train is provided, with the decision as to the
presence or absence of a maternal QRS wave at any given time being
based upon the most recent history of such waves. Accurate
detection is thus provided, despite changes in the general signal
level. An upper limit is built into the peak detector so that a
momentary large burst of noise will not drive the stored value to a
misleadingly high level.
The output of comparator 54 is used to fire a one shot (mono-stable
multi-vibrator) 56 having a pulse width (e.g., 140 milliseconds) as
wide as the widest expected maternal QRS signal.
FIG. 4 illustrates the output 57 of peak detector 52, the output 58
of comparator 54, and the output 59 of one shot 56.
Returning now to the fetal signal, the output of rectifier 42 is
fed to Paynter averaging filter 60, which in effect provides a
moving average (over a time span of some 17 milliseconds (the
optimum in a preferred range of 12 to 20 milliseconds), a time
constant chosen to match the expected duration of fetal QRS waves)
of signal value, further improving the ratio of fetal to maternal
signal strengths. FIG. 5 illustrates the Paynter output 62, which
includes fetal pulses 64 and maternal pulses 66, the latter of
course masking the former whenever the fetal and maternal
heartbeats merged.
The output of Paynter filter 60 and one shot 56 are fed to analog
gate 70, which closes during each firing of the one shot, thus
gating out of the Paynter output all but the leading edges of the
maternal pulses. The result is illustrated in FIG. 6, where the
spikes 72 are the leading edges of the blocked maternal pulses.
The result is passed through amplifier 74 to both a peak detector
76 and a comparator 78, which, just as did peak detector 52 a
comparator 54 for maternal pulses, provide for detection of fetal
pulses 64 with automatic thresholding. (The charging time constant
of the peak detector, about 3-4 milliseconds, is such that the
maternal spikes 72 will not cause a reset.) Upper and lower limits
are provided in the peak detector, the lower limit being set to
avoid mistaking low level noise for a fetal pulse. Although the
lower limit may rarely block out very weak fetal pulses, the device
preferably is set up so that a direct display of the output of
filter 32 can be switched on, this feature not being described in
detail here. While the lower limit may be fixed, greater accuracy
(in the face of changing general noise or fetal signal levels) is
obtained if the limit value is caused to change in accordance with
average signal value reaching the peak detector over a recent prior
period, e.g., over the past 10 seconds. Circuitry 79 providing such
a variable lower limit equal to, e.g., twice that average signal
value, is shown in FIG. 14. The outputs 80 and 82 of the peak
detector and the comparator are illustrated in FIG. 7. Pulses 84
correspond to fetal waves, the spikes 86 to the leading edges of
the maternal waves.
The output 82 of comparator 78 is then passed through a shift
register 90 (FIGS. 1, 11a) which provides a 32 millisecond delay.
The output of one shot 56 is used, each time it fires, to zero
register 90, thus blocking spikes 86. Thus, all remnants of the
maternal pulses are removed (though at the temporary cost of any
fetal pulses merged in the maternals) regardless of variation in
the maternal pulse rate. The shift register output 85 is
illustrated in FIG. 8. The register is gated to produce a four
millisecond pulse 87 coinciding with the falling edge of each pulse
84 (it having been discovered that the time between the falling
edges is a more accurate representation of the pulse spacing than
the time between the leading edges).
The resulting signal train will, in general, in comparison to the
real sequence of fetal heartbeats, have some gaps corresponding to
missing fetal signals, and will of course include some pulses
(noise) which do not correspond to real beats. The digital
circuitry to be described is designed to modify that signal train,
so far as possible, by restoring the missing fetal pulses and
removing the noise.
In general, the digital circuitry employs a phase lock loop, and a
sequence of windows (each window being essentially the positive
half of a square wave) is generated with a period and phase that
are updated on the basis of the recent history of the output of
shift register 90, in such a way as to tend to center the windows
on pulses 87. Any pulse 87 received outside a window is ignored for
readout purposes. The loop similarly ignores any two or more pulses
that fall within a single window. The value read out is the actual
time between pulses 87 when they occur singularly in consecutive
windows. When only one of two consecutive windows has a single
pulse, the readout is the time from that pulse to the center of the
window. When neither of two consecutive windows has a single pulse,
the readout is the time between the center of the windows. If too
many windows occur without single pulses, or if too many pulses
occur outside windows, readout is temporarily halted. Window phase
is updated only when single pulse windows occur, and window period
(frequency) is updated only when consecutive single pulse windows
occur.
The algorithm employed in the phase lock loop is illustrated in the
flow chart of FIG. 9. The window width (block 100) is roughly (a
more precise definition appears below) half the running period of
the loop, i.e., half the interval from the middle of one window to
the middle of the next. As shown in the flow chart, the pulse
pattern in the current and next previous windows controls the
values of "New Period" (which ultimately provides the rate
readout). "Average Period" (which in turn determines the actual
window frequency, as well as window width), and "Interval Between
Windows" (which in the absence of a window frequency adjustment,
controls window phase). In particular, if the current window
contains multiple pulses or no pulse, no adjustment is made in
either New Period (block 102) or Average Period (block 104), and
the Interval remains half the Average Period (block 106). If such a
window is followed by one in which a single pulse occurs, New
Period is adjusted to equal the time from the middle of the first
window to the pulse in the second (block 108), Average Period is
left unchanged (i.e., no frequency adjustment, block 110), and the
Interval is adjusted to equal three-fourths of Average Period minus
the time between the end of the current window and the pulse
therein (block 112). That is, window phase is adjusted so that the
next pulse 87 will be centered in its window (if pulse frequency
has not changed), yet without changing window frequency, since the
information in the previous window was unreliable and an erroneous
frequency adjustment based upon that unreliable information would
produce an error that would grow from window to window. Finally,
when two consecutive windows contain single pulses, New Period is
adjusted to equal the time between the successive pulses 87 (block
114), Average Period is adjusted to half the sum of the updated New
Period and the old Average Period (block 116, thus giving a
frequency adjustment, though only by enough to account for half of
any changes in the interval between pulses 87, to avoid
over-correction), and the Interval is adjusted to equal
three-fourths of the new Average Period minus the time between the
end of the current window and the pulse therein (i.e., phase is
adjusted too, block 118). (It should be noted that the value
readout is always New Period, which is not directly affected by the
frequency and phase adjustments just described.)
Because of its digital nature, employing high resolution counters,
the phase lock loop is able to operate over a wide range of
frequencies (e.g., 60-240 pulses per minute), and makes it possible
to postpone adjustment and readout decisions until the end of each
window.
A counter keeps track of the relationship between pulses 87 that
occur outside windows and those that occur singularly inside
windows. The count is incremented one for each outside pulse (block
117) and decremented one half for each single inside pulse (block
119). (The counter ignores multiple inside pulses). When the count
reaches 5 readout of New Period is halted (block 120). When the
count returns to less than 5 readout is resumed (block 122). Should
the count reach 8 or more, readout is halted (block 120), the
counter is zeroed, and a Restart routine is initiated (block
124).
In the Restart routine it is arbitrarily assumed that the pulse 87
which caused the counter to reach 8 corresponded to a real fetal
pulse, and the time to the next pulse 87 is measured (block 126).
Should that next pulse arrive in less than 250 milliseconds it is
ignored (block 128), because it would signify an unlikely fetal
rate of more than 240 beats per minute. On the other hand, should
that next pulse not arrive by 800 milliseconds, the counter is
zeroed and, upon the arrival of the next pulse 87, the Restart
routine is begun again (block 130); here again, restart at an
unlikely (here too low) rate is prevented. (Although the absence of
a pulse for 800 milliseconds corresponds to 75 beats per minute,
rather than the lower limit of 60 beats per minute to which
tracking is desired, allowing a restart at less than 75 would
substantially increase the risk of restarting at half the true rate
in the event that, over a period of time, maternal beats should
mask every other fetal beat. If, nevertheless, restart should occur
at half the true rate, the technique of counting pulses inside
windows at only half the weight as outside pulses ensures an
eventual reinitiation of the Restart routine.) Finally, still
referring to block 126, should a second pulse arrive within 250-800
milliseconds, New Period and Average Period are set equal to the
measured time between the two pulses (blocks 132, 134), and the
counter is set arbitrarily at 6 (block 136). Then, if the count
decrements to 4, readout is resumed; if it returns to 8, the
Restart routine is reentered.
The algorithm thus set forth strikes an excellent balance between
avoiding readout of erroneous information and minimizing readout
outages during which accurate information is lost.
FIG. 10 illustrates in block diagram form the implementation of the
phase lock loop and associated readout components. The detailed
circuitry appears in FIG. 11a-d, 12, 13. Referring to those
Figures, the signals from shift register 90 pass into New Period
measurement circuitry 150 (FIG. 11b), composed of two four-bit
counters 152, 154 with parallel loads a JK flip flop 156 for
clearing the counters. The New Period data goes to four-bit full
adders 158, 160 in Interval Between Window Generator 162 (FIGS.
11b, 11c), which adders also receive the Average Period data
generated in block 164 (FIG. 11b). The signals from the full adders
pass into the parallel loads of four-bit counters 166, 168, which
generate the Interval Between Windows data. The counter 166, 168
start out preset to the sum of one-fourth the Average Period plus
the value thus for counted in the New Period counters 152, 154 (the
latter value being the time between the just previous pulse and the
end of its window), and increment one during each clock cycle. Two
four-bit binary comparators 170, 172 signal when the count on
counters 166, 168 equals the stored Average Period value,
signifying the end of the Interval Between Windows. That signal
then passes to Window Generator 174 (FIG. 11c), which starts the
window and, with four bit counters 176, 178 controls its width at
half the Average Period value. Counters 176, 178 are loaded with
half the value of the last Average Period, and decrement one during
each clock cycle; at zero the correct width will have been
generated.
Restart counting circuitry 180 (FIG. 11a) includes four-bit up-down
counter 182 with parallel load, and a JK flip flop 184 which
generates a count of one for every other input for counting down,
providing the weighting factor described above.
The New Period value is stored in four-bit registers 190, 192 in
block 194 (FIG. 11d), and goes to digital-to-analog converter 196
(FIG. 11d) for conversion into an analog voltage. That voltage, a
measurement of period, passes to analog storage circuitry 198,
which includes a junction FET 200 and a high input impedance
operational amplifier 202, as well as logical circuitry to inhibit
readout when counter 182 is at 5 or more. From the storage
circuitry the signal goes to analog divider 204 which converts it
to rate information by generating an analog signal proportional to
the reciprocal of the period signal. The output from the divider is
amplified and given some D.C. offset (to restore the level to the
correct base line reference) in amplifier 206, and then is fed to
digital voltmeter readout 208 and strip chart recorder 210.
The gain between the input to storage circuitry 198 and the output
of divider 204 is adjusted so that each 10 millivolts of output
corresponds to a rate of one heart beat per minute. Thus, a digital
voltmeter which has a reading of 100 for a 1 volt input gives the
exact count of the heart reat in beats per minute. Similarly, the
strip recorder is set up for direct reading of the rate. Thus, off
the shelf readout devices can be used.
FIG. 12 illustrates a 2KHz oscillator 220 which is a source of
clock signals for the digital logic. The signal is divided down in
four-bit counter 222 to a 256Hz square wave T, along with faster
versions T' and T".
FIG. 13 illustrates a 1Hz oscillator 224 which generates a clock
pulse to control the readout rate.
Key parts employed in the particular embodiment described are as
follows:
1. Fairchild MA739C dual low noise operational amplifier is used
for amplifiers 12 and 13.
2. Teledyne Philbrick 1319 is used for bandpass stages 28 and
30.
3. Oscillators 29 and 31 are Signetics NE566.
4. Analog phase lock loops 33 and 35 are Signetics NE565.
5. All other operational amplifiers in the analog circuitry are
Fairchild MA741.
6. All analog comparators are National Semiconductor LM311.
7. All one shots are Fairchild 9601.
8. FET 200 is Motorola 2N4220.
9. The preamplifier power supply output transistors are Texas
Instruments 2N3704, and all other transistors are Fairchild
2N4275.
10. Matched diode pairs are Fairchild FA2000, and all other diodes
are Motorola 1N914.
11. Analog divider 204 is Teledeyne Philbrick 4452.
12. Digital to analog converter 186 is Analog Devices MDA8H.
13. The logic elements comprise Texas Instruments:
Sn 7400 quadruple two input NAND Gate
Sn 7402 quadruple two input NOR Gate
Sn 7408 quadruple two input AND Gate
Sn 7404 6 input inverter
Sn 7410 triple input NAND Gate
Sn 74107 jk flip Flop
SN 7483 4 bit full adder
Sn 7485 4 bit comparator
Sn 74193 4 bit counter (up-down) with parallel load.
Sn 7498 4 bit register with dual parallel load.
Sn 74164 8 bit serial shift register.
Other embodiments (e.g., picking up both fetal and maternal signals
with the same abdominally placed electrode; or for fetal rate
monitoring with scalp electrodes using a single filter train for
the fetal QRS; or for detecting, in any ECG signal, T waves by
elimination of the QRS, or even P waves by successive removal of
QRS and T waves, thus using three finter trains, this being useful,
e.g., for synchronizing the taking of X-rays in diastole or
systole; or for other sorts of physiological monitoring; or
"removing" maternal signals other than in the manner shown, as,
e.g., by tracking the maternal signals and inhibiting any response
thereto by the peak detector and the comparator; etc.) are within
the following claims.
* * * * *