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Patent 1193325 Summary

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Claims and Abstract availability

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(12) Patent: (11) CA 1193325
(21) Application Number: 404527
(54) English Title: HEART RATE DETECTOR
(54) French Title: DETECTEUR DE RYTHME CARDIAQUE
Status: Expired
Bibliographic Data
(52) Canadian Patent Classification (CPC):
  • 326/13.1
  • 326/1.6
(51) International Patent Classification (IPC):
  • A61N 1/39 (2006.01)
  • A61B 5/02 (2006.01)
  • A61B 5/0245 (2006.01)
  • A61B 5/04 (2006.01)
(72) Inventors :
  • IMRAN, MIR (United States of America)
  • KOLENIK, STEVE A. (United States of America)
(73) Owners :
  • MIROWSKI, MIECZYSLAW (Not Available)
(71) Applicants :
(74) Agent: STEWART & KOLASH, LTD
(74) Associate agent:
(45) Issued: 1985-09-10
(22) Filed Date: 1982-06-04
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data: None

Abstracts

English Abstract




HEART RATE DETECTOR

Abstract
A heart rate detector apparatus, particularly
for use in an implantable defibrillator, is disclosed.
The heart rate detector apparatus includes two distinct
detector circuits each responsive to ECG waveforms of
different characteristics. One of the detector
circuits is responsive to ECG waves having slew rates
above a predetermined threshold. The other detector
circuit is responsive to ECG waves having lower slew
rates, such as ECG waves of more sinusoidal shape. A
coupling circuit automatically couples one of the two
detector circuits to an output circuit, such as a
heart rate comparator. In a specific embodiment, the
heart rate comparator determines the heart rate,
compares the heart rate with a predetermined rate,
and, if the heart rate exceeds the predetermined rate
for a predetermined time period, provides an output
signal. The output signal may be used to enable a
defibrillating circuit to deliver a defibrillating
shock to the patient.


Claims

Note: Claims are shown in the official language in which they were submitted.




- 26 -
THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A heart beat rate detector responsive to incoming
ECG signals comprising:
input means for receiving an ECG signal;
wave detector means operatively coupled with the
input means for detecting an ECG waveshape having a slew
rate above a predetermined threshold and providing a wave
detector output signal for each detected waveshape;
zero-crossing detector means operatively coupled
with the input means for detecting an ECG waveshape having a
predetermined amplitude and providing a zero-crossing output
signal for each detected waveshape;
output means for receiving the wave detector
output signal and zero-crossing output signal; coupling
means for selectively coupling only and one of said wave
detector means and zero-crossing means with said output
means.
2. The detector of claim 1, wherein said
wave detector means provides no more than one wave
detector output signal per cardiac cycle.

3. The detector of claim 2, wherein said
coupling means selectively couples only one of said
wave detector means and zero-crossing means with said
output means dependent upon the rate of wave detector
output signals provided by the wave detector means.

4. The detector of claim 3, wherein said
coupling means couples said wave detector means with
said output means when the rate of wave detector
output signals exceeds a predetermined value.

5. The detector of claim 3, wherein said
coupling means couples said wave detector means with
said output means when the number of wave detector


- 27 -


output signals exceeds a predetermined value for a
first predetermined time period, and the spacing
between such wave detector output signals is substan-
tially constant.

6. The detector of claim 5, wherein said
coupling means retains said wave detector means
coupled with said output means for at least a second
predetermined time period.

7. The detector of claim 5, wherein said
coupling means retains the wave detector means coupled
with said output means until no wave detector output
signals are received in at least a second predetermined
time period.

8. The detector of one of claims 4, 5,
or 6, wherein said coupling means couples said zero-
crossing means with said output means when said wave
detector means is not coupled with said output means.

9. The detector of claim 1, wherein said
wave detector means comprises means for differentiating
the ECG signal and for taking the absolute value of
the differentiated signal to obtain the slew rate,
comparing means for comparing the slew rate with a
predetermined slew rate threshold to provide a slew
rate output signal when the detected slew rate exceeds
the slew rate threshold.

10. The detector of claim 9, wherein said
wave detector means further comprises means responsive
to the slew rate output signal for generating the
wave detector output signal.


- 28 -

11. The detector of claim 10, wherein said
means for generating the wave detector output signal
comprises a monostable multivibrator means for providing
a single, uniform wave detector output pulse in
response to each slew rate output signal.

12. The detector of claim 11, wherein said
monostable multivibrator means is responsive to no
more than one slew rate output signal per cardiac
cycle.

13. The detector of claim 11, wherein said
monostable multivibrator means is responsive to no
more than one slew rate output signal in a predetermined
refractory time period.

14. The detector of claim 13, wherein said
monostable multivibrator means includes means for
varying the predetermined refractory time period
dependent upon the cardiac cycle to be monitored.

15. The detector of claim 1, wherein said
output means comprises a comparator means for determining
the aggregate number of wave detector output signals
and zero-crossing detector output signals received
per unit of time, and comparing the aggregrate number
per unit of time with a predetermined rate.

16. The detector of claim 15, wherein said
comparator means includes heart rate output means for
providing an output signal of the aggregate signals
received per unit of time, said output signal being
the actual heart rate.

17. The detector of claim 15, wherein said
comparator means includes a comparator output means for

- 29 -

providing a comparator output signal when the aggregate
signals per unit of time exceed a predetermined rate.

18. The detector of claim 15, wherein said
comparator means compares the aggregate signals per
unit of time with a predetermined rate on a beat-by-
beat basis.

19. The detector of claim 15, wherein said
comparator means includes a comparator output means
for providing a series of comparator output signals
when the aggregate signals per unit of time exceed
the predetermined rate on a beat-by-beat basis.

20. The detector of claim 19, wherein said
comparator means further comprises integrating means
for integrating the series of comparator output
signals over a predetermined time period and providing
a detector output signal when the integrated series
of comparator output signals exceed a predetermined
value.

21. A heart beat rate detector responsive
to incoming ECG signals over a number of cardiac
cycles, each cardiac cycle including a wave packet of
P, Q, R, S and T waves, each wave packet representing
a heart beat, wherein said detector comprises:
first detecting means for detecting a wave
packet having a first predetermined characteristic
and providing a first output signal when said wave
packet is detected;
second detecting means for detecting a wave
packet having a second predetermined characteristic
and providing a second output signal when said wave
packet is detected;

- 30 -

output means for receiving the first and
second output signals; and
coupling means for selectively coupling
only one of said first and second detecting means
with said output means whereby the aggregate number
of first and second output signals represents the
number of heart beats.

22. The detector of claim 21, wherein the
first detecting means detects a wave packet having a
rate of change of voltage versus time greater than a
predetermined threshold value.

23. The detector of claims 21 or 22,
wherein the second detecting means detects a wave
packet having an R-wave amplitude greater than a
predetermined amplitude.

24. The detector of claim 21, wherein said
first detecting means includes means for detecting
the rate of change of the P, Q, R, S and T waves in
each wave packet, comparing the rate of change with a
predetermined threshold value, and providing a single
first output signal for each wave packet when the
rate of change of any of the P, Q, R, S and T waves
in the wave packet exceeds the predetermined threshold
value.

25. The detector of claims 21 or 24,
wherein said second detecting means includes a com-
parator means for comparing the amplitude of the
R-wave within a wave packet with a predetermined
amplitude and providing a second output signal when
the R-wave amplitud exceeds the predetermined amplitude.


- 31 -
26. The detector of claims 21 or 24, wherein said
second detecting means comprises a high gain amplifier
providing a comparator means for comparing the amplitude of
the R-wave within a wave packet with a predetermined
amplitude and providing a second output signal when the
R-wave amplitude exceeds the predetermined amplitude.
27. The detector of claim 24, wherein said
coupling means couples only said first detecting
means with said output means when a predetermined
number of first output signals occur at a substantially
constant frequency over a first predetermined time
period and retains said first detecting means coupled
with the output means for at least a second predetermined
time period.

28. The detector of claim 27, wherein said
coupling means couples said second detecting means
with said output means whenever the first coupling
means is not coupled with said output means.

29. A system for use with an automatic
defibrillator for defibrillating the heart of a
patient experiencing abnormal cardiac rhythm, com-
prising:
input means for receiving ECG waveforms;
processing means coupled with said input
means for processing the ECG waveforms in accordance
with a probability density function to develop a
probability density function output signal;
a heart rate detector coupled between said
input means and a processing output means, said heart
rate detector comprising,
first detecting means for detecting an
ECG wave packet having a first predetermined
characteristic and providing a first output
signal when said wave packet is detected;
second detecting means for detecting
an ECG wave packet having a second pre-



- 32 -

determined characteristic and providing a second
output signal when said wave packet is detected;
rate detector output means for receiving
the first and second output signals and for
providing a rate detector output signal to the
processing output means when the aggregate number
of first and second output signals exceed a pre-
determined rate; and
coupling means for selectively coupling one
of said first and second detecting means with
said rate detector output means whereby the
aggregate number of first and second output
signals represents the number of heart beats;
and
processing output means for coupling said
processing means and heart rate detector with a
defibrillating pulse generator for initiating the
discharge of a defibrillating shock upon receiving a
predetermined signal from at least one of said processing
means and said heart rate detector means.


30. The system of claim 29, further com-
prising means for coupling said rate detector output
means to said processing output means wherein the
rate detector output signal initiates the defibril-
lating pulse generator to deliver a shocking pulse to
the patient's heart.

31. The system of claim 29, wherein the
first detecting means detects a wave packet having a
rate of change of voltage versus time greater than a
predetermined threshold value.

32. The system of claims 29 or 31, wherein
the second detecting means detect a wave packet





- 33 -

having an R-wave amplitude greater than a predetermined
amplitude.

33. The system of claim 29, wherein said
first detecting means includes means for detecting
the rate of change of the P, Q, R, S and T waves in
each wave packet, comparing the rate of change with a
predetermined threshold value, and providing a single
first output signal for each wave packet when the
rate of change of any of the P, Q, R, S and T waves
in the wave packet exceeds the predetermined threshold
value.

34. The system of claims 29 or 33, wherein
said second detecting means includes a comparator
means for comparing the amplitude of the R-wave
within a wave packet with a predetermined amplitude
and providing a second output signal when the R-wave
amplitude exceeds the predetermined amplitude.

35. The system of claims 29 or 33, wherein said
second detecting means comprises a high gain amplifier
providing a comparator means for comparing the amplitude of
the R-wave within a wave packet with a predetermined
amplitude and providing a second output signal when the
R-wave amplitude exceeds the predetermined amplitude.

36. The detector of claim 33, wherein said
coupling means couples only said first detecting
means with said rate detector output means when a
predetermined number of first output signals occur at
a substantially constant frequency over a first
predetermined time period and retains said first
detecting means coupled with the rate detector output
means for at least a second predetermined time period.


37. The system of claim 36, wherein said
coupling means couples said second detecting means







- 34 -

with said rate detector output means whenever the
first coupling means is not coupled with said rate
detector output means.

38. The detector of claim 7, wherein said
coupling means couples said zero-crossing means with
said output means when said wave detector means is
not coupled with said output means.



39. A method of detecting abnormalities in the
operation of a heart comprising the steps of receiving an ECG
signal from the heart, comparing the slew rate of the ECG
signal with a predetermined threshold and providing a
slew rate output signal if said slew rate exceeds said
threshold,
comparing the amplitude of said ECG signal with
a predetermined value and providing a zero-crossing
output signal if the detected signal exceeds said
predetermined value, selecting one of said output signals
and connecting it to an output means to indicate an
abnormality in the operation of said heart.


40. A method according to claim 39 including the
step of monitoring said slew rate output signal and
maintaining connection between said slew rate output signal
and said output means for as long as high slew rates occur
within a predetermined time period.

41. A method according to claim 40 including the step
of coupling said zero-crossing output signal with said
output means upon termination of the connection with said
slew rate output signal.





Description

Note: Descriptions are shown in the official language in which they were submitted.


~1~3~

~escription
~IEART RATE DETECTOR




Technical Field
The present invention rela-tes to a heart rate
detector system, and more particularly, ~o an improved
heart rate detector capable of use with an implant,able
defibrillator for defibrilla-ting the heart of a patient
when the patient experiences a life-threatening
arrhythmia.

Background Art
In recent years, suhstantial progress has been
made in the development of defibrillat:ion techniques for
providing an effective medical response to various heart
disorders or arrhythmias. Earlier efforts resulted in
th~ development of an electronic standby defibrillator
which, in response to detection of abnormal cardiac
rhythm, dischaxged sufficient energy, via electrodes
connected to the h2art, to depolarize the heart and
restore it to normal cardiac rhythm. Examples of such
electronic standby defibrillators are disclosed in
Ca~adian Patents Nos. 956,700 and 981,338.
Past efforts in the field have also resulted
in the development of implantable electrodes for use in
accomplishing ventricular defibrillatlon (as well as other


' ,~
;-


~3~


remedial techniques3~ In accordance with such tech~niques, as disclosed (or example) in Canadian Patent
No. 1,091,304, an apex electrode is applied to the exter-
nal intxapericardial or ex-trapericardial surace of the
heart, and acts against a base electrode which can be
either similarly conformal or in the form of an intravas-
cular catheter. Such electrode arrangements of the prior
art, as disclosed in the aforementioned Canadian patent
can employ independent pacing -tips associated wi-th eit~er
a base electrode or an apex electrode, or both.
Recent efforts also have resulted in the
development of techniques for monitoring heart activity
~for the purpose of determining when defibrillation
or cardioversion is necessary), which techni~ues
employ a probability density function for determining
when ventricular fibrillation is present. Such a
techni~ue, employing the probability density function,
is disclosed in Canadian Patents Mos. 1,087,691,
1,106,920 and 1,106,921.
In accordance with this latter technique of
the prior art, when the probability density function
is satisfied, fibrillation of the heart is indicaked.
However, recent experience has shown that, wi-th certain
unusual ECG patterns, the prior art probability
density function detector, if not optimally adjusted,
can he "triggered" not only by actual ventricular
fibrillation, but also by some forms of high rate
ventricular tachycardia, and low rate ventricular
tachycardia as well, particularly in the presence of
ventricular conduction abnorrnalities. The possibility
of such trig~eriny in the presence of some high rate
tachycardia is acceptable because high rate tachycardia
often can be fatal if present at such a rate that
sufficient blood pumping no longer is accomplished.

3~


However, triggering in the presence of non-life
threatening, low rate tachycardia could be considered
a pxoblem. Therefore, it has been determined that
there is a need for a system and method for distin
guishing between ventricular fibrillation and high
rate tachycardia, on the one hand/ and low rate
tachycardia, on the other hand.
One response to the need discussed above is
described in Canadian Patent Application No. 383,279 1,
filed August 5, 1981. There, a probability density
function circuit, responsive to differentla~ed ECG
signals from the heart electrodes, is used in conjunction
with a heart rate circuit whereby the probability density
function (PDF) circuit activates a defibrillator pulse
generator only when the PDF circuit is enabled by the
heart rate circuit. Such enabling occurs when the heart
ra-te exceeds a pre~etermined value reflecting what is
considered to be a danyerous high rate tachycardia.
The success of the latter system depends,
in larye part, on the reliability and accuracy of the
heart rate detector circuit. Heart rate detectors,
per se, are known in the art. Such heart rate detectors
are typically designed to be responsive to incoming
ECG waveforms of a predetermined type. For exampl~,
it is known to detect a heart rate by the use o~ a
zero-crossing detector. In such detectoxs, the
zexo-crossi.ng points of the ECG waveform reflect a
periodic event in the cardiac cycle~ When, however,
the ECG waveform is characterized by rather steep
slopes~ for example when the rate of change of the
R-wave vol~age is steep, or spiky, then the use of
such a system to detect the zero-crossings loses

J~


accuracy. The steep 610pe R~wave complex, with its
accompanying Q and S segments, results in multiple
counts per cardiac cycle, giving an artificially high
rate reading, which could, in certain cases, be
significant.
It is also known in the art to provide a
heart rate detector responsive to those ECG signals
having steep or "spiky" slopes~ Some such detectors
respond to the ECG signal and provide an output
r~sponsive to such steep slope signals. Such output
may be provided by a sl~w rate detector which compares
the slope, or slew rate, with a slew rate threshold
and provides an output signal reflecting the number
of high slew rate signals detected. A problem inherent
in such a system is the detection of a heart rate
when the ECG signal is more sinusoidal than spiky.
In such cases, the slew rate, or rate of chang~ of
the ECG voltage versus time, characteristic is small.
Thus, the detector may not pick up such siynal~,
thus, resulting in detection of an inaccurate low
heart rate.
In very ill patients, .it is not unusual to
find that the ECG waveforms change from time-to-time.
The ECG could present itself as a spiky waveform for
a time, and then become more sinusoidal, or vice
ver~a. Ra~e detectors, of the types described above,
would not be versatile enough to effectively respond
to both types of ECG waveforms.
It is thus seen that the prior art heart
rate detectors fail to provide the required flexibility
in monitoring EC~ signals characterized by both spiky
ECG waveforms and the more sinusoidal ECG waveforms.
Prior art detectors can be designed to work very
efficiently with one or the other of such waveforms,
but not both. Therefoxe, i~t has been determined that

2~


a need exists to provide a flexibl~ accurate and
reliable heart beat rate detector that is operable
over a broad range of detected ECC ~aveforms.
According to the present invention tnere
is provided a he~rt beat rate detector responsive to
incoming ECG signals comprising:
input means for receiving an ECG siqnal;
wave detector means operative~y coupled
with the input means for detecting an ECG waveshape
having a slew rate above a predetermined threshold
and providing a wave detector output signal for each
detected waveshape;
zero-crossing detector means operatively
coupled wi.th ~he input means for detecting an ECG
waveshape having a predetermined am21itude and ~roviding
a zero-crossing output sisnal for each detected waveshape;
output means for receiving the ~ave detector
output signal and zero-crossing output signal;
coupling means for selectively coupling only
and one of said wave de~ector means and zero-crossing means
with said output means.
According also to the present invention there is
provided a method of detecting abnormalities in the
operation of a heart comprising the steps of receiviny an
ECG signal from the heart, comparing the slew rate of the
ECG signal~with a predetermined threshold and providing a
slew rate output signal if said slew rate exceeds said
threshold,
comparing the amplitude of said ECG signal with a
predetermined value and providing a zero-crossing output
signal if the detected signal exceeds said predetermined
value, selecting one of said output signals and connecting
it to an output means to indicate an abnormality in the
operation of said heart. Such heart rate detector has
particular utility in an automatic implanta~le defibrillator

~33~5
- 5a -

system wherein the heart rate detector is used in
conjunction Wittl a probability density function circuit,
such combina~ion as described in the co-pending Langer et al
Canadian patent application No~ 383,279, filed A~gust 5,
1981. However, it should be noted that the heart rate
detector of the present invention also has significant
utility in a heart pacing system or in any other environment
where t~e heart rate is required to be reliably, efficiently
and accurately measured.
The hear-t rate detector of the present
invention is responsive to an incoming ECG signal
having a series of wave packets, each wave packet
including P, Q" R, S and T waves, as is well-defined
in the art. The heart rate detector includes two
mutually exclusive detection circuits that are respon-
sive to incoming ECG waves having different character-
istics. These detection circuits are coupled with an
output circuit. Depending upon the incoming ECG wave
characteristic, the coupling circuit automatically
and selectively couples one of the two detection
circuits with the output circuit to provide an accurate
count of the heart rate.
In particular, the two mutually exclusive
detection circuits of the present invention include a
high slew rate detector, and an amplitude threshold
detector. When the incoming ECG wave is characterized
by spiky waves having a high slew rate, the high slew




,~s,~

32~
-- 6 ~

rate detector is coupled with the outpu-t circuit.
~hen -the incoming ~C~ wave is charac~eriæe~ ~y lower
slope, or more sinusoidal, ECG signals, then the
threshold amplitude detector is coupled with the
output circuit.
More particularly, when the incoming ECG
waves have a slew rate above a predetermined level,
and such "high" slew rate signals occur at a pre-
determined freguency over a predetermined time, in a
manner as will be described herein, then the slew
rate detector circuit provides an accurate determln~tion
of the heart rate. If, however/ the incoming ECG
waves have a slew rate below the predetermined level,
and such "lo~" slew rate signals occur at a predeter-
mined rate, then the amplitude threshold detectorcircuit provides an accurate determi.nation of the
heart rate.
The preferred embodiment of the present
invention provides an input for receiving an EC~
signal. A slew rate detector circuit is coupled with
the input for detecting an ECG wave shape having a
slew rate above a predetermined threshold and providing
an output signal for each detested wave shape~ Also
coupled with the input is an amplitude threshold
detector circuit that detects an ECG wave shape
having a predetermined amplitude and provides an
output sigrlal for each detected wave shape. An
output circuit is provided to receive the two detector
output signals. A coupling circuit selectively
couples only one or the other of the detector circuits
with the output circuit. The high slew rate detector
circui~ is coupled with the outpu-t circuit when a
predetermined number of high slew rate signals fr~m
the slew rate detector occur at a substantiall~
constant freguency over a first predetermined time

33~



period. When such conditions occur, the high slew
rate detector remains coupled with the output circuit
for as long as high slew rate signals occur within at
least a second predetermined time period. At all
S other times, the output circuit is coupled with the
ampli~ude threshold detector.




, . . .
,,

a~
-- 8

An embodiment of the invention will become
apparent by reference to the following drawings, in which:
FIGURE 1 is a block diagram of the heart rate
detector of the present invention in a defibrillator circuit.
FIGURE 2 is a block diagram of the double-duty
delay circuit shown in Fig. 1.


Best Mode for Carrying Out the Invention
The heart rate detector 2 of the present
invention responds to amplified, incoming ECG waveforms
and includes a slew rate detector 4 and an amplitude
threshold detector 6, each coupled with an input
circuit 8 that provides the amplified ECG waveforms.
One or the other of these detectors 4 and 6 are
coupled, via a coupling circuit 10, with a digital
rate comparator output circuit 1~ depending on the
characteristics of the ECG waveforms. The comparator
output circuit 12 processes the aggregate signals
received from the slew rate detector 4 and amplitude
threshold detector 6 (the total siynals reflecting
the nun~er of heart beats), and provides a detector
output signal (on line 14) when the heart rate exceeds

- 9

a predetermined, or preprogrammed, rate over a pre-
determined period of time.
The heart rate detector 2 may have utility
in a broad range of applications, such as implantable
defibxillators or pacers, or external monitoring
equipment. A heart rate detector in a defibrillator
circuit is shown. In particular, a probability
density function circuit 16 is provided having its
input responsive to an amplified and differentiated
ECG signal. Logic circuitry 18 interconnects the PDF
circuit output with the heart rate detector output
such that the PDF circuit 16 is coupled with the
defibrillating pulse generator (not shown) only upon
occurrence of a detector ou~put signal, which reflects
high rate tachycardia. Details of the circuitry will
now ~e described.
ECG input terminal 20 is coupled to suitable
heart electrodes (not shown), via an interface (not
shown), to receive an ECG input signal. The heart
electrodes may include a superior vena cava (or base)
electrode and an apical cup (or patch) electrode in
association with a patient's heart. Such electrodes
are schematically shown in the co-pending Langer et
al patent applicationr
2~
The incoming ECG signal includes a series
of wave packets reflecting heart beats, each wave
packet including P, Q, R, S and T waves as is understood
in the art. Each wave packet defines a cardiac
cycle, as the term is used herein.
The input terminal 20 is connected with a
conventional EC5 amplifier 22 having an automatic
gain control (AGC~ circuit 24. In this manner, input
signals of different amplitudes can be handled by the
overall circuit, as is well known in the art.

~v~

-- 10 -

Co~nected to the ECG amplifier 22 are the
two detector circuits ~ and 6 of the present invention.
The slew rate detector 4 includes a differentiator
and absolute value circuit 26 which takes the absolute
value of the first derivative of the incoming amplified
ECG signal. This ahsolu-te value of the first derivative
is defined as the slew rate, which is the instantaneous
rate of voltage change per unit of time. In ~he
context of the present invention, the slew rate can
be suitably measured in terms of microvolts per
millisecond. The differentiator and absolute value
circuit 26 is con~entional and known -to those of
ordinary skill in the art.
The slew rate value from the differentiator 26
is provided as an input to a conventional threshold
comparator 28. The slew rate is compared with a
predetermined slew rate threshold value. When the
sl~w rate exceeds the slew rate threshold, a slew
rate output signal is provided on the comparator
output line 30. The slew rate threshold is predeter-
mined before the unit is implanted and is set by
adjusting the variable resis-tor 32 connected to the
negative input terminal 34 of the comparator 28. (It
is envisaged that slew rate also can be set, or
programmed, from outside the body by telemetry or
other appropriate techniques.) The slew rate threshold
may be set depending upon the ECG characteristics of
the particular patient, but typically should be set
so as to provide a slew rate output signal only for
relatively high slew rates, i.e., slew rates resulting
from ECG signals of relatively spiky, or high slope,
angles.
The slew ra-te output signals are provided
over line 30 to the input of a monostable (one-shot)
multivibrator 36 having a variable refractory period.


. "

~33~


The monostable multivibra~or 36 provides a unifo~m
output pulse on line 38, as is well k-nown in -the art.
This output pulse is defined herein as the wave
detector, or slew rate de-l:ector, output signal, or
pulse.
It is desirable, for proper operation of
the system, that only one wave detector out~ut signal
b~ provided in a single cardiac cycle in ordex that
the wave detector output signal properly represents
the numbex of heart bea~s. As stated above, each
cardia~ cycle includes a wave packet of P, Q, R, S
and T waves. Generally, only the R wave slew rate
will be sufficientl~ high to provide a slew rate
output signal from the comparator 2~ to the monostable
multivibrator 36. ~owever, for certain patients, one
of the other waveforms within the wave packet, par-
ticularly the P or T waves, might also have a high
slew rate such that the slew rate threshold value set
by the variable resistor 32 is exceeded~ Thus, more
than one slew r~te output sigrlal per cardiac cycle
may be provided as the input to the monostable multi-
vibrator, which, in turn, would result in multipl.e
wave detector output signals on line 38 for only a
single heart beat.
In order to avoid the potential problem set
Eorth above, the refractory period of the monostable
multivibrator 36 is adjusted, via input terminals 40,
so that when a slew rate output signal from comparator 28
t~iggers the monostable multivibrator 36, subsequen-t
slew rate output signals occurring within a predetermined
refr~ctory ~ime period do not further trigger the
multivibrator. The refractory period is set so that
only o~e slew rate output signal within a wave packet,
or cardiac cycle, w111 trigger the multi~ibrator 36.
Once triggered, the multivibrator trigger point is

- 12 -

inhibited for a certairl refractory period/ typically,
between 100 and 200 milliseconds. This rate can be
set depending upon the pa-tient's normal heart rate.
If the patient has a relatively low heart rate, then
the refractory period should be set higher than would
be the case for a patient with a high heart rate.
Similarly, i the patient has a high heart rate, then
the refractory period is set lowex, to ensure that
each slew rate output signal from the slew rate
threshold comparator 28 is counted.
Generally, the refrac-tory period is preset
for a particular patient prior to implantation.
~owever, an automatic variable refractory period
adjustment mechanism may be provided, and implanted,
to vary the refractory period depending upon heart
rate changes.
The monostable multivibrator 35 of the
present invention is a conventional circuit and its
design is known to one of ordinary skill in the art.
The multivibratox 36 provides a uniform pulse output
on line 38 ~the wave detector output signal or pulse).
The width of the output pulse should not be so wide
that the monostable multivihrator 36 does not reset
in time to receive subsequent slew rate output signals
~rom the comparator 28 indicative of subse~uent heart
beats. Similarly, the pulse width should not be so
narrow that the multivibrator is retriggered upon
receipt of a subsequent slew rate output signal
within the same wave packet.
The wave detector output signal from the
monostable multivibrator 36 is provided on the output
line 38 of the monostable multivibrator, which line 38
is coupled with an AND gate 42 of the coupling
circuit 10, to be described further below.

,1 ,3 ~ f ~ P ~
- 13 -

The second detector circuit of the present
invention is the amplitude threshold detector 6.
This threshold detector 6 includes a conventional
high gain amplifier 44 having one input 46 grounded
and the other input 48 connected with the ECG amplifier
via a low-pass filter 47. The low-pass filter 47
filters out ECG waveforms having "spiky" characteristics
and passes only the more sinuso:idal ECG waveforms.
The amplifier 44 responds to amplified ECG signals
having an R~wave greater than a predetermined value.
When the amplified ECG signal exceeds the threshold,
which is arbitrarily chosen as yround, then the
amplifier 44 provides a zero-crossing output signal
which is coupled to A~D gate 50 of the coupllng
circuit 10. The threshold detector 6, ha~ing the
negative input of the amplifier 44 grounded, thus
operates as a zero-crossing detector.
The coupling circuit 10 will n~w be described.
Coupling circuit 10 is defined here.in as the logic
circuit comprised of AND gates 42 and 50, OR gates 52
and 54, double~duty dela~ circuit 56, and inverters 58
and 60. These circuit elements are interconnected in
such a r~nner that the outputs of the slew rate
detector circuit 4 and amplitude threshold, or zero-
crossing, detector 6 are coupled with the digital
rate comparator output circuit 12. AND gate 42
receives the wav~ detector output signal over line 38.
The A~D gate 42 output line 62 is connected to the
input of OR gate 54. Similarly, the amplitude -threshold,
or zero-crossing, detector 6 outpu-t is connected, via
line 64, to the input of AND gate 50. ~he AND gate 50
output line 66 is coupled -to -the OR gate 54. As will
be described hereinbelow, only one of AND gates 42
and 50 is enabled at the same time and thus the OR
gate 54 receives either the ~ero-crossing outpu-t

3~5
- 14 ~

signals ~over line 66) or wave detector output signals
(o~er line 62~ depending upon which of AND gates 42
and 50 is enabled. Th~ OR gate 54 output is provided,
over line 68, to the digital rate co~nparator output
5 circuit 12. The signals from the output of OR gate 54
reflect the number o heart beats detected.
AND gate 42 has three inputs 70, 72, 74.
One of -the inputs 72 is connected to the output
line 38 from the monostable multivibrator 36 and
receives the wave, or slew rate, detector ou-tput
signals. Input 70 of the AND gate 4~ is connected to
a slew xate detector inhibit line 76. If, under
certain circumstances, it is desired to monitor ECG
signals solely using the zero~crossing detector 6, a
zero input over line 76 to the AND gate 42 may be
provided which will disenable the AND gate 42. Such
inhibition o the slew rate detector may be justified
depending upon the ECG waveforms of a particular
patien-t. If the slew rate detector circuit 4 is to
be maintained in the system, then the input termi n~l 70
of the AND gate 42 is at a high or "1" state. The
third input terminal 74 of the AND gate 42 is coupled
with a double-duty delay circuit 56 via an invertor 60.
The double-duty delay circuit 56 is designed
such that its output 80 is normally at high, or "1",
state. The "1" state is inverted by inverter 60 so
that the AND gate term~ n~l 74 has a low, or "zero"
state, and ~ND gate 42 is disabled. The output of
the delay circuit 56 is also coupled to an OR gate 52
which has an output line 78 coupled with AND gate 50.
When the double duty delay output 80 is in a high, or
"1", state, the "1" signal is transferred through the
O~ gate 52 over line 78 to the input terml n~l 82 of
the AN~ gate 53, thus enabling the AND gate 50 to
pass zero~crossing output signals from the zero-crossing

~33~
~ 15 -

detector 6 to the OR gate 54 and, in turn, to the
digital rate comparator 12. On the other hand, when
the double-duty delay circuit output ~0 is low, or in
a "0" state, the third terminal 74 of the AND gate 42
is encibled, and -the terminal 82 of the AND gate 50 is
disenabled. Wave, or slew rate, detector output
signals from the mo~os~able m~ltivibrator 36 are thus
coupled through AND gate 42 to OR gate 54 and, in
turn, to the digital rate comparator output circuit 12.
It is thus seen that the double-duty delay circuit 56
alternately enables one of the AND gates 42 and 50 so
that either the zero-crossing detector 6 or the slew
rate detector 4 is coupled to the digital rate com
parator output circuit 12.
The double~duty delay circuit 56 is shown
in detail in E'igure 2. The circuit includes an
input 84 which is coupled with the output line 38 of
the monostable multivibrator 36 and thus receives
wave detector output pulses from the wave, or slew
rate, detector circuit 4. These wave detector output
pulses are provided to input 202 of a conventional
digital counter 200. The counter 200 has a seco~d
input 204 that receives clockiIlg pulses, such as a
32Hz clock signal. The counter 200 counts the clocking
pulses and, if a predetermined number of clocking
pulses are consecutively counted, the counter 200
provides a high, or "1", signal on the cou~ter output
line 206. For example, if clocking pulses provided
at input 204 are counted for a predetermined time
~0 perio~, e.g~, 2 seconds, then the counter 200 oukput
becomes hi~h, or in its "1~' state. However, the
cou~ter 200 is reset upon receipt of each wave detector
output pulse provided to input 202. When reset, the
counter output is 1GW, or in its "0" state. It is
thus seen that so long as wave detector output signals

~33~ZP~
- 16 -

from the slew rate detector circuit 4 occur within a
predetermined time period, such as 2 seconds, then
the counter 200 output is "Oi~; if no wave detector
output signal is forthcoming for such 2 second interval,
then the counter 200 output is "1".
The counter output line 206 is connected to
input 208 of a conventional set~reset flip flop 210.
The flip~flop 210 has a second input 212 and an
output 80. The output 80 is coupled to i~verter 60
and OR gate 52~ as described with respect to Fisure 1.
The flip-1Op 210 has the following charac
teristics. When a high, or l'1", signal is provided
at input 208, the output 80 is high, or in its "1"
state. ~hen a high, or "1", sîgnal is provided at
input 212, in a manner to be described, the output 80
is low, or in its "0" state. The flip-flop 210 is
controlled, and switches state, solely by "1" signals
applied to one of the inputs Z08 and 212.
Output line 80 is furth~r coupled to input 214
of ~ND gate 216. The other input 218 of AND gate 216
is connected to input 84 to receive pulses from the
slew rate detector circuit 4. Thus, when the output 80
is in its "1" state, the AND gate 216 is enabled to
pas~ wave de-tector output pulses from the slew rate
detector circuit 4. These wave detector output
pulses are passed by AND gate 216 to an RC circuit 220.
The RC circuit 220 includes a capacitor 222
and resistor 224 connected in parallel. The output
of RC circuit 220 is connected to an in~erter ~26.
The inverter 226 output is connected to a reset
terminal 228 of a counter 230, substantially identical
in operation to the previously descri~ed counter ?0O,
and including a second inpu~ 232 coupled to a pre-
determined clocking source, such as a 32Hz clocking
signal.

3Z~

~ 17 ~

When a wave detector output pulse from the
slew rate detector circuit 4 is passed by AND gate 216
to the RC circuit ~20, the capac:itor 222 is immediately
charged and begins a gradual exponential decay, as is
well known in ~he ar~. The deccly ~ime depend~ on the
RC characteristics. In the present case, the RC
characteristics are such that upon receipt of a wave
detector output pulse, the capacikor 222 is substan-
tially immediately charged to a voltage level exceeding
the threshold needed for the inverter 226 to change
its state. The capacitor then gradually decays until
the voltage drops below the threshold. If a second
wave detector output pulse is received by the RC
circuit before the voltage drops below the threshold,
then the inverter 226 r~m~i n~ in its changed state,
until the voltage drops below the threshold. It is
thus seen that if a predetermined number of wave de-
tector output pulses are received by the RC ci.rcuit 220,
and if these output signals are spaced apart by a
predetermined time, the threshold voltage level, at
which the inverter 226 is operative, will continuously
be exceeded. The RC characteristic is correlated
with the predetermined time pexiod o -the counter 230,
as will be described below.
Let us suppose that the output 80 in its
"1" state. (As described with reference to Figure 1,
when GUtpUt 80 iS in its "1" state, the zero-crossing
detector 6 is coupled to the digital rate comparator 12.)
The AND ga-te 216 is thus enabled to pass any wave
detector outp~t pulses that might be received from
the slew rate detector circuit 4. If no wave detector
output pulses are received (evidencing that the input
EC~, is of the low slew rate type~, no voltage is
presented to the inverter 225. The input of inverter 226
is thus low (~elow threshold), or "0". The "0"


, ,

r

- 18

signal is inverted to provide a l'l" signal a~ -the out-
put of inverter 226 and hence ~o ~he reset terminal 2Z8
of counter 230. The output o counter 230 is thus
llOI', which is provided a~t inpu~ of ~lip-flop 210
A "0" signal at input 212 does no~ change th~ state
of the flip~flop, as discussed above.
Now let us suppose that a high slew rate
si~nal is de~ected by the rate de~ector such that a
wave detector output pulse is provided by the multi-
vibrator 36 ~Figure 1) to ~he input 84. This signal
is passed by AND gate 216 to the RC circuit 220.
(Such a signal is also provided to reset inpu-t 202 of
counter 200 which, in turn, provides a "0" signal on
line 206 to the flip-flop input terminal 208. ~owever,
as discussed above, a ~iO" signal at input 208 does
not change the state of flip-flop 210 and the output 80
will remain in its "1" state.) Capacitor 222 is
immediately charged above the inverter threshold
voltage level and the inverter 226 now "sees" a "1"
input. The ~'1" input to inverter 226 i~ inverted to
a "0" output which is provided to the reset terminal 228
of the counter 230. The counter 230 thus is enabled,
and begins to count the 32EIz signals provided at its
other in~ut 232.
Let us suppose that the wave detector
output signal at terminal 84 was an ~no~ly, and that
no subsequent output signal is provided wi-thin the
time period before the capacitor 222 decays below the
threshold voltage level (on the order of two seconds).
That is, no subse~lent pulse is provided to the R~
circuit 220, via the AND gate 21~, before the capaci-
tor 222 decays to a level below the threshold level.
Under such circumstanGe, th~ input voltage to the
inverter 226 will fall below threshold, i.e., to a
"0" state, the inverter 226 output will switch back

- 19 -

to a "l" state, and thus will reset the counter (at
terminal 228). This rese~ will occur before the
counter 230 has counted it~ predetermined n~mber of
clock pulses; i.e., the reset will occur before a
predetermined ~ sec.) time in~erval. ~hus, the
output o counter 230 will not have changed its state
to a "1" output; rathex the counter 230 rem~; n~ at
its "0" state and ~he flip~flop 210 is not reset.
The flip-flop 80 remains in its "1" state.
Let us now consider the condition where a
second pulse fxom the slew rate detector circuit 4 is
received by AND gate 216 before the capacitor 222
decays below the threshold voltage level. This
second pulse recharges capacitor 222 to its fully
charged state, such that the capacitor maintains a
voltage above the inverter threshold level for a -time
greater than the predetermined time in-terval of
counter 230, thus main-taining the counter 230 in its
enabled state to count a sufficien-t number of clock
pulses such that the output o~ counter 230 switches
to its "l" state. As will be recalled, this "1"
siynal from counter 230, provided at input 212 o
flip-flop 210, changes the ~lip-flop ~0 to a "0"
state. The AND gate 216 is now disabled. Similarly,
since the output 80 is "~", the slew rate detector
circuit 4 is coupled to the digital rate comparator 12
(Figure 1). So long as further high slew rate signals
are provided at least every two seconds to terminal 84,
the output 80 rPm~;n~ in its "0" state.
From the above description, i-t should be
apparent that to maintain the input voltage to in-
verter 226 above the threshold level, and hence to
maintain counter 230 in its high s-tate (so that the
zero-crossing detector 6 is uncoupled from, and the
slew rate detector circuit 4 is coupled to, the

~ ~ 3~J~ ~

-- ~0 ~

digital rate comp~rator 12), the wave detector output
pulses from the slew rate detector circuit 4 must
occur above a particular rate and must also occur at
substan-tially equal spacing. For ex~mple, let us
assume that the pr~deterrined time period of the
counter 230 is two seconds, and further assume that
it is desirable to "switch over" to ~he slew rate
detector circuit g when -two consecutive wave detectGr
output pulses are received. Upon recei.pt of the
first wave detector output pulse to ~he RC circuit ~20,
the capacitor charges up, substantially instantaneously,
to excee~ the threshold voltage of inverter 226, and
then begins to decay. If the second consecutive wave
detector output pulse occurs 1/2 second later, and no
further pulse is received within the 2 second window,
then the voltage to inverter 226 will fall below the
threshold level before the 2 second period of co~mt-
er 230 is completed. The counter 230 will L~e reset
the "instant" the capacitor voltage falls helow the
threshold of inverter 226, and hence will not change
from its "0" state, maint;;n.ny the output 80 in its
"1" state; no "chanyeover" to the slew rate detector
circuit 4 occurs.
Similarly, if the second wave detector
output pulse occurs 1 1/2 seconds after the f.irs-t,
then the voltage to the inverter 226 will have decayed
below threshold before the second pulse is received.
Again, even though counter 230 was enabled by the
first pul~e, it would be reset the "instant" the
capacitor volta~e fell below the threshold of in-
verter 226 (i.e. r not continuously exceeded during
the 2 second window of counter 230); thus, counter 230
will not chan~e from its "0" state.
With reference to Figure 1, the double-delay
circuit 56 functions in the following manner. Assume,

~3~3~

~ 21 -

as a starting poin-t, that the zero-crossing det~ctor 6
is coupled to the digital rate compara-~or ou-tput
circuit 12. The double~duty delay circuit output 80
is in its "1" state. Wave detector output sign~ls
from the slew rate detector circuit 4 are now received.
The double-duty delay circuit 56, over a first pre-
determlned time period, counts the number of wave
detector output signal pulses that have a relatively
constant frequency. If ~he number of constant frequency,
i.e., substantially uniformly spaced, pulses exceeds
a predetermined number within -the first predetermined
time period, then the double-duty delay output line 80
is shifted from a normally high to a low, or "0"
state. It rem~n~ in this 1l0ll state for at least a
second predetermined time period. The second pre-
determined time period may be the same length as the
first predetermined time period. If subsequent wave
detector output pulses occur within the second pre-
determlned time period, the delay circuit output 80
rP~ln~ in its "0" state. If, however, the time
period between successive wave detector output signal
pulses increases, i.e., if ~o wave detector output
signal pulses occur within the second predekermined
time period, then the delay circuit 56 output 80
switches from its "0" state to its high, or "1"
state.
It is thus seen that so long as high slew
rate output pulses of predetermined number and fre
quency are received by the delay circuit 56, then the
zero~crossing detector 6 is uncoupled from, and the
slew rate detector 4 is coupled to, the digital rate
comparator output circuit 12. If, however, the
number of high slew rate output signals falls below a
predetermined le~el, in a pxedetermined time period,
then the coupling circuit 10 couples the zero-crossing

3;~

- 22

detector 6 with the digital rate cornparator outpu-t
circuit 12. Such zero-crossing detec~or 6 r~m~
coupled to the outpu~ circuit 12 until the double-duty
delay circuit 56 again switches sta-te, as described
above.
The coupling circuit 10 of the prPsent
invention thus ensures -that when the ECG si~nal is
characterized by "spiky", or high slew rate waveforms,
the slew rate detector 4 is used to monitor the ECG
signals. On the other hand, if the slew rate of the
incoming ECG signal is more sinusoidal, then the
coupling circuit 10 couples the zero-crossing detector 6
to the ou-tput circuit 12. This alternate switching
between the detectors 4 and 6 ensures a reliable and
accurate count of the heart b~ats.
It should be apparent that some heart beats
might be missed. For example, the initial wave
detector output signals rom the multivibrator 36,
which are provided to the double~duty delay circuit 56,
will not be enabled by the ~ND gate 42 to pass to the
OR gate 54, since the AND gate ~2 is not enabled
until a~ter a first predetermined time period.
Generally, the first predetermined time period is set
between 1 and S seconds~ with the 2-5 seconds preferred.
(Although such high slew rate signals may not be
counted by the slew rate detector circuit 4, it is
still possible that they may be counted by the zero-
cros~ing detector 6, if they happen to be passed by
the low-pass filter 47.~ Similarly, if the AND
gate 42 is enabled a~ter a first predetermined time
period, and then no further high slew rate signals
are received, the zero-crossing detector will be
disenabled for at least a second predetermined period
of time and any heart beats of low slew rate will be
missed. As a practical matter, however, the number

- 23 -

of heart beats that are missed by the h art rate
detector circuit 2 will be relativ~ly small since the
doublP-duty delay circuit 56 is designed so tha~ the
first and second predetermined time periods are not
5 so great th~t the missed heart beats would have a
critical effec~. Moreover, also as a practical
matter, it is unlikely that a patient's ECG waveform
will be drastically al~ernating between high and low
slew ra-tes in such a manner that a cri~ical number of
heart beats will be missed.
The output circuit ].2 includes a digital
ra-te com~arator 86. The digital rate comparator is
of conventional design (such as i.ncluding a digi-tal
magnitude comparator, a latch and a counter) and has
an inpu-t 88 coupled with the output line 69 of the OR
gate 54 from the coupling circuit 10. The signals at
the input 8g reflect the number of heart beats from
either the zero-crossing detector 6 or the slew rate
detector 4. The digital rate comparator 86 includes
program rate input terminals 90 for .reading into the
digital rate comparator a predet~rmined, or prepro-
grammed, rate. The digital rate comparator 86 receives
the heart beat signals and determines, on a bea-t-by-beat
basis, the actual heart rate. This heart rate is
compared with the programmed .rate and when the heart
rate ex~eeds the programmed rate, a comparator output
signal is provided on the comparator output lin~ 92.
~elay circuit 93, which could be an integrator as is
well known in the art, integrates -the comparator
ou~put signals over a predetermined time and provides
a detector output signal on line 14 if the number of
comparator output rate signals exceeds a predetermined
number in a predeterm'ned time. Generally, the delay
circuit 93 provides a safety feature to prevent
spurious signals from starting ~he defibrillating

~33;2~

- 24 ~

pulse generator. The delay circuit 93 may provide an
output signal if two comparator outpu~ pulses are
received within a four second interval.
The digital rate comparator 86 also includes
readout ~erminals 9~ for reading out the actual heart
rate. This actual heart rate readout may not be
needed for defibrilla-tor or pacer operations, but
circumstances may exist where the actual rate is
desired. If ~he device is implanted in a human body,
the readout can be by telemetry or the like.
When the heart rate de~ector 2 is used in a
defibrillator circuit, as sho~n in Figure 1, the
detector output signal on line 14 i5 provided to the
inputs of two RND gates 96 and 98. AND gate 96 has,
as its other input, the output from the PDF circuit 16.
The output of AND gate 96 is coupled to an OR gate 100
which, in turn, is coupled to a defibrillator pulse
generator ~not shown) to initiate a defibrillatiny
shock. Thus, when the PDF circuit characteristics
are satisfied and the heart rate output exceeds a
prede-term-ned value, the AND gate 96 is enabled, and
the PDF circuit is coupled with the deibrilla~ing
pulse generator.
Under certain circumstances, a defibrillating
shock may be desired solely dependent upon abnormal
heart rate. Under such conditions, AND gate 98 has~
at t~rr-n~l 102, a high or "1" input to enable the
defibrillating pulse generator to be activated solely
by th~ output 14 of the heart rate detector circuit.
If such feature is not desired, then the terminal 102
of the AND gate 98 has an inhibit or "O" input.
While preferred forms and arrangements of
the invention have been shown and illus~rated, it is
to be clearly understood that various changes ln

~Ld.~a3~3~

-- 25 --

detail and arrangement may be made without departing
from the spirit and scope of this disclosure.

Representative Drawing

Sorry, the representative drawing for patent document number 1193325 was not found.

Administrative Status

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Administrative Status

Title Date
Forecasted Issue Date 1985-09-10
(22) Filed 1982-06-04
(45) Issued 1985-09-10
Expired 2002-09-10

Abandonment History

There is no abandonment history.

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $0.00 1982-06-04
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
MIROWSKI, MIECZYSLAW
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 1993-06-16 26 1,267
Drawings 1993-06-16 2 62
Claims 1993-06-16 10 401
Abstract 1993-06-16 1 33
Cover Page 1993-06-16 1 18