U.S. patent number 3,824,990 [Application Number 05/158,481] was granted by the patent office on 1974-07-23 for method and apparatus for producing sample electrocardiograms.
This patent grant is currently assigned to Instruments for Cardiac Research, Inc.. Invention is credited to Gerhard M. Baule.
United States Patent |
3,824,990 |
Baule |
July 23, 1974 |
METHOD AND APPARATUS FOR PRODUCING SAMPLE ELECTROCARDIOGRAMS
Abstract
An electronic instrument for medical use measures the time
intervals between QRS complex portions of the electrical signal
wave representing heartbeats. The intervals are quantized in
digital form. The occurence of each subinterval is stored. Every
incoming time interval is compared with the stored values. The
instrument, upon receiving and comparing a novel interval, for
example, either too short or too long, will activate an
electrocardiograph recorder. The instrument produces a relatively
small number of electrocardiographic (ECG) records, in the form of
paper strips, but those strips are likely to contain a history of
arrhythmic heart activity.
Inventors: |
Baule; Gerhard M. (Camillus,
NY) |
Assignee: |
Instruments for Cardiac Research,
Inc. (Syracuse, NY)
|
Family
ID: |
22568326 |
Appl.
No.: |
05/158,481 |
Filed: |
June 30, 1971 |
Current U.S.
Class: |
600/515 |
Current CPC
Class: |
A61B
5/0245 (20130101); A61B 5/333 (20210101); A61B
5/337 (20210101) |
Current International
Class: |
A61B
5/0436 (20060101); A61B 5/0432 (20060101); A61B
5/024 (20060101); A61B 5/0245 (20060101); A61b
005/04 () |
Field of
Search: |
;128/2.6A,2.6B,2.6F,2.6G,2.6R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Gerber; Eliot S.
Claims
I claim:
1. The method of automatically recording arrhythmic heartbeats in a
patient, comprising attaching electrodes to the patient to a
monitor his heartbeat, amplifying the electrical wave signals
received on the electrodes, measuring the time intervals between
similar portions of the said electrical wave signals, converting
said timed intervals into quantified interval and, by the
employment of an electronic circuit, storing the set of said
quantified intervals, comparing subsequent intervals with said set
of stored intervals and commencing the recording of an
electrocardiogram and storing of said subsequent interval upon the
comparison of an interval which does not match any of said set of
stored intervals.
2. The method of claim 1 wherein the said similar portions of the
signals are the peaks of the QRS complex.
3. The method of claim 1 and including the step of operating the
recorder after the said commencement for a short predetermined time
period.
4. An instrument for the detection of arrhythmic heartbeats,
including electrodes adapted to be connected to a patient, an
amplifier connected to said electrodes, a detector of a selected
portion of the wave signal and a signal delay device both connected
to said amplifier, an interval timer to time the interval between
heartbeats connected to said detector, a memory device connected to
said timer to store a set of said intervals, each one of which is
different from the others of the set, a comparison device connected
with said detector and to said storage device to compare intervals
with said set of stored intervals and to produce an operating pulse
and to store said composed interval only upon a finding of
non-identity, an ECG recorder connected to said delay device and
connected in series with said comparison device, and a period timer
connected to said recorder, whereby upon receipt of said operating
pulse said recorder records the signals from said delay device for
the period set by said period timer.
5. An instrument as in claim 4 wherein said detector is a detector
of the peaks of the QRS complex and produces a trigger pulse only
at each said peak.
Description
BACKGROUND OF THE INVENTION
This invention relates to the instrument, analysis and processing
by means of an electronic instrument of heart activity, and more
particularly to the field of electrocardiography.
DESCRIPTION OF THE PRIOR ART
It is possible to detect and amplify voltages associated with the
contraction of heart muscles by means of electrodes attached to a
patient. The voltages are amplified and the voltage waveforms
displayed by a pen marking device on a strip of paper
(electrocardiograph).
It is considered good medical practice to continuously monitor a
patient's electrocardiographic waveform (ECG) for a minimum of
several days following a heart attack. Continuous monitoring is
also used during operations and during periods of intensive care.
It is believed that continuous monitoring for as little as 30
minutes gives considerably more information on arrhythmias than the
standard ECG which may take less than 1 minute. The monitoring of
ECG is particularly useful in persons who have had coronaries and
are on antirhythmic drug therapy. Long term records (hours or days)
of the ECG have shown value in predicting coronary prone persons,
and in spotting brief periods of arrhythmias, which sometimes are
potentially fatal, and sometimes are responsible for such symptoms
as dizziness or light-headedness. Long term ECG records are
sometimes recorded on audio magnetic tape for subsequent analysis,
usually at higher than normal "playback" speeds.
At the standard ECG speed of 25mm/sec, a continuous record would
use 90 meters of paper/hour. This is clearly impractical. As an
alternative, an oscilloscope display is used in operating rooms,
coronary care and intensive care units. An oscilloscope display is
evanescent and does not furnish a document for more leisurely study
or as a patient record. For such "permanent" records, such as ECG
paper strips of magnetic tapes, it is desirable to obtain from the
vast amount of possible records only a few samples. These samples
should include representations of "critical portions" such as the
occurrence of a premature beat, a missed beat (heart block), a run
of tachycardia, etc.
The selection of critical portion samples is presently accomplished
by having a specially trained nurse, who more or less continually
observes the oscilloscope display, turn on the ECG recorder when a
section of possible interest occurs in the displayed waveform. The
ECG signal to the recorder is delayed from 2 to 20 seconds, with
respect to the oscilloscope display, so that the event can be
recorded after it has occurred. When the long term monitoring is by
means of tape recording, the analyst reviewing the tape usually
searches for and writes out, using a pen recorder and paper strip,
those samples he deems important to include in the summary
record.
The desirability of automatically monitoring and printing out
appropriate sample records is generally recognized. The continual
24-hour observation of an oscilloscope by highly trained persons is
expensive and limits such monitoring to the very high risk
patients. Visual monitoring is also usually less than perfect due
to lapses of attention and fatigue effect. This is particularly
true with the common practice of having one observer simultaneously
monitor four to eight oscilloscope displays. When reviewing tape
recorded data during high speed playback (usually 60 times normal
speed) only very competent persons are able to spot short intervals
of waveforms representing heart arrhythmia, which intervals may be
displayed for only a fraction of a second.
An automatic sample read-out system should not give an
overabundance of samples of the same thing or run continuously. A
number of circuits have been proposed to detect ectopic (premature)
heart beats based on beat-to-beat (R-R interval) timing or which
operate on waveform morphology. An ectopic beat detector can signal
a recorder to turn on and if the recorder is fed with the delayed
ECG waveform the record of the ectopic beat will be automatically
captured. However, that system has the disadvantage that in some
persons ectopics occur frequently -- six to 15 occurrences a minute
is not uncommon, so that the recorder would run almost
continuously.
OBJECTIVES OF THE INVENTION
The objectives of the present invention in which the beat-to-beat
intervals of the patient are compared to a set of such stored
intervals so that only novel intervals will operate the recorder
for a short fixed time, are:
a. to provide an instrument and method which will detect arrhythmic
heart beats in a patient and which will initiate the ECG recording
of the patient upon such detection;
b. to provide such an instrument and method that will not initiate
an overabundance of ECG recordings on frequent premature
heartbeats;
c. to provide such an instrument and method which does not need
constant attention by trained or other personnel but will operate
entirely automatically;
d. to provide such an instrument and method which will provide a
set of samples initiated by arrhythmic heart activity, which
samples are likely to provide information of interest to medical
personnel;
e. to provide such an instrument and method which provides a
permanent record, which may be retained as part of the patient's
record, and which is relatively small in size and yet likely to be
a history of those portions of heart activity of particular
interest.
SUMMARY OF THE INVENTION
The instrument of the present invention works with the conventional
electrodes to detect heart activity. The voltages are amplified and
the intervals between successive beats that have occurred area
measured, that is, the R-R interval is measured. The set of
intervals that have occurred is stored in a memory unit. The value
of each incoming interval is compared to the stored set.
When an interval occurs which is not yet included in the stored
set, for example, too long an interval due to a missed heartbeat,
the instrument initiates the operation of a conventional ECG
recorder which then runs for a predetermined time period. The ECG
to the recorder is appropriately delayed so that the inscribed
record includes the novel R-R interval. The new R-R interval value
is then added to the stored set so that future occurences of the
value will not initiate the recorder operation.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1a-1e and FIGS. 4a and 4b are ECG waveforms showing the
intervals between heart beats, and the range of intervals resulting
from those waveforms;
FIGS. 2a and 2c are block diagrams of the circuit of the instrument
of the present invention;
FIG. 2b is a timing diagram illustrating the comparison function
which takes place to either activate or not activate the ECG
recorder; and
FIGS. 3a-3e depict the state of the storage device; and
FIGS. 5a and 5b are histograms of heart activity.
DESCRIPTION OF THE PREFERRED EMBODIMENT
In conventional medical terminology, the first small deflection of
the waveform associated with the depolarization of the auricles of
the heart, is commonly referred to as the "P wave." This deflection
is followed by a complex of deflections, associated with the
depolarization of the ventricles, commonly referred to as the "QRS"
complex. The complex of deflections is followed by a longer
deflection, associated with the depolarization of the ventricles,
commonly referred to as the "T wave." One set of each of the P, QRS
and T deflections occurs with each heart beat. The time period
between QRS complexes or between R deflections is denoted the "R--R
interval" and is shown in the figures as a line with arrows at both
its ends. This interval is generally not less than .2 seconds and
seldom exceeds 2.0 seconds.
Non-normal rhythms of the heart are generally referred to as
arrhythmias. For the normal person the R-R intervals vary somewhat
about an average value. An absolutely constant heart rate (a fixed
R--R interval) is not typical of a normal heart, and in this sense
is an arrhythmia; a very high heart rate (a short R--R interval)
and a very low heart rate (a long R--R interval) are also usually
referred to as arrhythmias. Detecting the presence and the type of
an arrhythmia is of great value in the diagnosis and management of
cardiac patients.
Of particular interest in cardiac diagnosis and management, and of
significant clinical importance, is arrhythmia that is due to
"premature beats," "ecoptic beats" or "premature ventricular
contractions" ("PVCs"). R--R intervals are so labeled and the beats
are unlabeled. The R--R interval from the QRS complex of the normal
beat to the QRS complex of the premature beat is less than the R--R
interval between normal beats; this interval is the "coupling
time." For single PVCs the R--R interval between it and the
following normal beat is usually longer than the R--R interval
between normal beats. This interval is called the compensatory
pause.
As shown in FIG. 1a, the R--R intervals are taken between the peaks
of the QRS complex. The instrument then places that measurement in
digital form, using a scale of a second divided into 25 parts
(subintervals), the scale being shown in FIG. 1b. The R--R
intervals will be from .2 to 2 seconds long, i.e., 5 to 50
subintervals.
In FIG. 1c a normal R--R interval, i.e., a heartbeat of a normal
patient at the highest rate, is designated A and the R--R interval
at the lowest normal rate is designated B. The range of intervals,
on the scale, is A-B.
In contrast, as shown in FIG. 1d, in the samples from a "PVC"
subject, i.e., one having premature beats, the normal beat interval
is "A," the shortest coupling time is C, the longest coupling time
is D and the interval for the compensatory pause is E. FIG. 1e
shows the chart with samples from a patient having a heart with AV
blockage (the entire QRS complex is missing). The sample produced
will show the block. As shown, the missed beat interval F falls
outside the range of normal intervals A.
The block diagram of the circuit of the present invention of FIG. 2
shows electrodes 10, 11 and 12 which are adapted to be connected to
a patient. The electrodes 10, 11 and 12 are connected to
differential amplifier 13. The output of amplifier 13 is to a delay
device 14 and to a QRS detector 15, for example, a peak detecting
circuit. The QRS detector produces a sharp trigger pulse at each
QRS peak and screens out other portions of the ECG waveform such as
P waves, T waves, muscle artifacts, electrode movement artifacts,
etc. The delay device may be a magnetic recording device or an
electronic delay line.
The QRS detector 15 is connected to an interval timer 16 which
measures the intervals between the output pulses of the QRS
detector. The measurement is in .04 second subintervals. The
interval timer 16 is connected to a set of memory cells 17, which
may be a set of flipflop circuits connected in a register. Each
memory cell is either in a state 0 or a state 1. The record samples
are obtained over a period, for example, a 1-hour period. At the
beginning of each period all memory cells are reset to state 0. The
memory cells are combined with the R--R interval measuring circuit
such that the occurrence of a given value of R--R interval will set
the corresponding memory cell to state 1. Once a cell is 1 it
remains 1 until reset (new period). All further occurrences of the
same R--R interval will thus have no effect.
The memory cells (storage device) establish a set of intervals
which have already occurred. The inhibitor 18 is connected to QRS
detector 15 and to the storage device 17. Each trigger from the QRS
detector 15 tries to turn the recorder 19 on. As shown in the
comparison function diagram of FIG. 2b, if that particular
subinterval has occurred previously in the period (i.e., memory
cell is 1) it is inhibited and has no effect. However, if that
subinterval has not occurred before in the period, for example,
because it is either too long or too short, it triggers a
conventional monostable circuit whose output turns on the ECG
recorder 19 for a period of several (preferably 2.6) seconds.
Preferably the ECG recorder 19 is a conventional single pen moving
paper strip graph recorder. The stylus drive 20 of the recorder 19
is operated from the delay device 14. The preferred speed of the
ECG record is 25mm/sec so that each .04 subinterval of the interval
timer 16 corresponds to 1 mm of paper movement of the ECG
recorder.
The operation of the circuits of FIGS. 2a and 2c is shown in
connection with FIGS. 3a-3e. In FIG. 3a all the memory cells are at
zero at the beginning of a data period.
Assuming the first few beats have "normal" R--R intervals some of
the boxes (corresponding to memory cells) in the normal range
become 1, see FIG. 3b. FIGS. 3c and 3d show the result of a
premature beat, the short R--R interval from the premature to the
preceding normal beat (coupling time) causing an "early" memory
cell to go to 1. The following long R--R interval (compensatory
pause) between premature and succeeding normal beats causes a
"late" memory cell to go to 1. By the end of the data period all
memory cells corresponding to the R--R intervals that have occurred
are 1, see FIG. 3e.
Each trigger from the QRS detector 15 tries to turn the recorder 19
on. If the memory cell for the R--R interval just measured (i.e.,
interval from the trigger to its predecessor) is not yet 1, it
succeeds. If the memory cell is 1, it is inhibited. Thus the
recorder will only be turned on when a novel R--R interval appears.
The maximum number of records cannot exceed the number of
quantisized R--R intervals, about 45, and one sample record will be
produced for each R--R interval which does occur.
The signal to the recorder stylus 20 is the output of the ECG
amplifier 13 delayed in time by delay device 14. Preferably the
delay time is 2 seconds, although longer times are equally
feasible. A suitable period for the recorder to remain on is 2.6
seconds. As shown in FIG. 4a the last beat of the pair whose R--R
interval caused the sample will be .6 seconds or 15 mm from the end
of the record (the extra .6 second insuring that the T wave will be
recorded).
The number of samples cannot exceed the number of R--R intervals
that actually occurred and will often be less since a "new" R--R
interval can occur while the recorder is still running due to a
previous "new" R--R interval. The preferred mode of operation of
the recorder is to have it run for, say, 2.6 seconds as measured
from the last of the "turn on" signals. This will result in some
records lasting over 2.6 seconds, see FIG. 4b , so that the record
will contain all the beat pairs giving rise to new R--R
intervals.
The sampling technique of the present invention is most valuable
when combined with an R--R interval histogram. The height of the
bars in the histogram, tells the number of occurrences of a given
R--R interval, and the sample record, described above, tells what
type of beats caused this bar. Use of a proper mounting form can
make it easy to reconstruct which sample goes with which bar. FIG.
5a shows an example of an R--R interval histogram which is
characteristic of isolated PVCs. The center clusters are the R--R
intervals between normal beats, and the early and late clusters are
due to the premature beats. Adding the bar heights in either gives
the total number of PVCs that occurred. The ECG samples would
include specimens of normal beats and PVCs.
Much of the circuitry shown in FIG. 2a is common with that needed
to produce the histogram. The memory cells previously described
would be the least significant digit controlling the bar height. A
simple point of view is that a sample is taken when, and only when,
a bar starts, i.e., goes from a count of 0 to a count of 1. FIG. 5b
depicts some variations on the sampling scheme. One could take a
sample only when the count reaches, say, 5. This might be
advantageous to avoid records due to a few artifacts just starting
a bar. If desired, it would also be easy to arrange for multiple
samples on a bar, say at counts 1, 5, 50, 100 and 200. FIG. 5b
shows a switching arrangement that permits this type of
flexibility.
* * * * *