U.S. patent number 3,842,357 [Application Number 05/351,621] was granted by the patent office on 1974-10-15 for calibration of electrical blood-pressure monitoring equipment.
Invention is credited to Thomas B. Hutchins, IV.
United States Patent |
3,842,357 |
Hutchins, IV |
October 15, 1974 |
CALIBRATION OF ELECTRICAL BLOOD-PRESSURE MONITORING EQUIPMENT
Abstract
Producing calibrating voltage wave forms for electrical
blood-pressure monitoring equipment. Such production includes (1)
the generation of a nonrectangular monopolar voltage wave form
having a leading edge with twice the slope of the trailing edge,
and a constant amplitude portion between such edges, and (2) from
this pulse the forming of a bipolar wave form which is the first
derivative of the monopolar wave form. The monopolar wave form is
specially configured to approximate closely the voltage wave form
generated by a conventional blood-pressure monitoring catheter as
such follows normal human arterial blood pressure.
Inventors: |
Hutchins, IV; Thomas B.
(Portland, OR) |
Family
ID: |
23381635 |
Appl.
No.: |
05/351,621 |
Filed: |
April 16, 1973 |
Current U.S.
Class: |
73/1.59; 327/170;
324/74; 331/77 |
Current CPC
Class: |
H03K
4/94 (20130101); A61B 5/0215 (20130101); A61B
5/7239 (20130101) |
Current International
Class: |
A61B
5/0215 (20060101); H03K 4/00 (20060101); H03K
4/94 (20060101); H03k 004/02 () |
Field of
Search: |
;328/127,188 ;307/268
;331/77,113 ;128/2.06 ;324/74 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Heyman; John S.
Attorney, Agent or Firm: Kolisch, Hartwell, Dickinson &
Stuart
Claims
It is claimed and desired to secure by Letters Patent:
1. Apparatus for producing electrical voltage wave forms usable
especially for calibrating an electrical instrument for monitoring
human arterial blood pressure, said apparatus comprising
generating circuit means operable to generate a monopolar first
electrical voltage wave form having a leading edge with a
predetermined positive slope of one value, and a trailing edge with
a predetermined negative slope of another value which is one-half
said one value, said leading and trailing edges being separated in
time by a substantially constant amplitude portion,
differentiating circuit means operatively connected to said
generating circuit means to receive such a first wave form,
operable, on receiving the same, to differentiate it and produce a
bipolar second electrical voltage wave form having a first-in-time
rectangular pulse with one polarity, and one amplitude which is
directly proportional to the value of the slope of said leading
edge of said first wave form, and a second-in-time rectangular
pulse with the opposite polarity, and another amplitude which is
directly proportional to the value of the slope of said trailing
edge of said first wave form, said two pulses being separated by a
constant zero-voltage portion of said second wave form, which
portion corresponds in time to said constant amplitude portion of
said first wave form, and
output means for coupling said first and second wave forms to such
a monitoring instrument whereby proper operation of said instrument
is verified by said constant zero-voltage portion of said second
wave form.
2. The apparatus of claim 1, wherein said generating circuit means
includes a first subcircuit operable to produce a rectangular
voltage pulse, and a second subcircuit operatively connected to
said first subcircuit, operable to receive such a pulse, and to
produce therefrom, for supplying to said differentiating circuit
means, a nonrectangular voltage pulse with such having said leading
and trailing edges and said constant amplitude portion.
3. The apparatus of claim 2, wherein said second subcircuit
includes means for independently adjusting the values of the slopes
of said leading and trailing edges.
4. A method of calibrating an electrical instrument which is for
monitoring human arterial blood pressure comprising
generating a monopolar first electrical voltage wave form having a
leading edge with a predetermined positive slope of one value, and
a trailing edge with a predetermined negative slope of another
value which is one-half said one value, and with said leading and
trailing edges being separated in time by a substantially constant
amplitude portion,
differentiating said first wave form to produce a bipolar second
wave form having a first-in-time rectangular pulse with one
polarity, and one amplitude which is directly proportional to the
value of the slope of said leading edge of said first wave form,
and a second-in-time rectangular pulse with the opposite polarity,
and another amplitude which is directly proportional to the value
of the slope of said trailing edge of said first wave form, said
two pulses being separated by a constant zero-voltage portion of
said second wave form, which portion corresponds in time to said
constant amplitude portion of said first wave form, and
coupling said first and second wave forms into said instrument
whereby proper operation of said instrument is verified by said
constant zerovoltage portion of said second wave form.
5. The method of claim 4, wherein said generating is accomplished
by first producing a rectangular voltage pulse, and then from such
pulse producing a nonrectangular voltage pulse having said leading
and trailing edges and said constant amplitude portion.
Description
BACKGROUND AND SUMMARY OF THE INVENTION
This invention pertains to the following of arterial blood pressure
in a human being, and more particularly, to a method and apparatus
for accurately calibrating an electrical instrument, such as a
recorder or an oscilloscope, for monitoring such pressure.
In many medical procedures it is important, or at least desirable,
to be able accurately to monitor changes in arterial blood pressure
in a patient. In this connection, one usually wishes to observe not
only the instantaneous changes (in time) of the actual pressure,
but also the first derivative of these changes whereby even minor
variations in the systolic and diastolic actions of the heart can
readily be detected.
Usually, the actual sensing of such blood pressure is done by means
of arterial catheterization, using a catheter equipped to generate
an electrical signal which reflects blood pressure changes. For
example, a catheter capable of performing extremely accurately in
this respect is disclosed in U.S. Pat. No. 3,710,781. Such a
catheter may be connected to a buffer amplifier which serves both
to isolate the patient from electrical shock, and to amplify
signals from the catheter to a usable level. Such an amplifier, for
instance, is disclosed fully in my prior-filed copending
application, Ser. No. 269,747, filed July 7, 1972, for
"Electromedical Patient Monitoring System".
However, satisfactory means has not heretofore been available for
accurately calibrating the monitoring device (recorder,
oscilloscope, etc.) so that information derived from such a
catheter and amplifier is knowingly accurately presented and/or
recorded by the device.
A general object of the present invention, therefore, is to provide
a novel method and apparatus for assuring the accurate calibration
of such monitoring device.
A related object is to provide such a method and apparatus which is
relatively simple to practice and use, and which is extremely
reliable.
According to the invention, what is contemplated is the generation
of a pair of carefully controlled voltage wave forms one of which,
in configuration, closely approximates the electrical wave form
usually obtained from a catheter following normal arterial blood
pressure, and the other of which is an accurate first derivative of
the first-mentioned wave form. The novel means used to accomplish
such action includes a generating circuit which is operable to
generate a monopolar first electrical voltage wave form having a
leading edge with a positive slope similar to the slope found in
the leading edge of a normal arterial blood pressure wave form, and
a trailing edge with a negative slope similar to the negative slope
of the trailing edge of the usual blood pressure wave form, and
with these edges separated in time by a substantially common
amplitude portion. Working in conjunction with this generating
circuit is a differentiating circuit which, on receiving a wave
form supplied by the generating circuit, produces a bipolar second
voltage wave form having separated positive and negative pulses
whose amplitudes are directly proportional to the slopes of the
leading and trailing edges, respectively, of the wave form
generated by the generating circuit. Means is provided in the
generating circuit for adjusting, and accurately controlling, the
respective slopes of the mentioned leading and trailing edges.
The various other objects and advantages attained by the invention
will become more fully apparent as the description which follows is
read in conjunction with the accompanying drawings.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a simplified block diagram illustrating a blood-pressure
monitoring system employing apparatus constructed according to the
invention.
FIG. 2 is a circuit diagram of a generating circuit as
contemplated.
FIG. 3 is a circuit diagram of a differentiating circuit employed
in the invention.
And, FIG. 4 is a graph illustrating, on a common time scale, a
number of voltage wave forms which are significant in the operation
of the system of FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
Turning now to the drawings, and referring first to FIG. 1, here is
shown generally at 10, in block form, a blood-pressure monitoring
system employing apparatus constructed in accordance with the
present invention. At its input end, so-to-speak, system 10
includes a blood-pressure monitoring catheter 12, and at its output
end, a dual-input, dual-track, ink-stylus recorder 14. Both of
these devices are conventional in construction, and thus are
neither illustrated, nor described, in detail herein. Catheter 12
herein is one constructed in accordance with previously referred to
U.S. Pat. No. 3,710,781.
Interconnecting these two devices are a buffer amplifier 16, a
selector 18, an amplifier 20, a calibration generating circuit 22,
and a differentiating circuit 24. Amplifier 16 herein comprises a
circuit such as that disclosed in the above-mentioned patent
application. Selector 18 may simply be a switch through the
actuation of which it is possible to feed amplifier 20 with signals
coming either from amplifier 16 or from circuit 22. Amplifier 20 is
unity-gain, low output impedance amplifier of any suitable
design.
Signals from catheter 12 are supplied the buffer amplifier through
a conductor 17, and are fed from this amplifier to selector 18 via
a conductor 19. Circuit 22 supplies signals to the selector over a
conductor 21--the selector feeding amplifier 20 through a conductor
23. The output of amplifier 20 couples to one of the inputs in
recorder 14 through a conductor 25, and couples to the input of
circuit 24 via conductor 25 and a conductor 27. Finally, the output
of circuit 24 connects with the other input in the recorder through
a conductor 29.
With catheter 12 and buffer amplifier 16 constructed as above
indicated, and when the catheter is inserted for use in an artery,
blood pressure change, in either direction, of 1 mm. Hg produces a
voltage change of 1 mv. at the output of the buffer amplifier. An
increase of pressure causes a rise in voltage, and vice versa.
While the apparatus of the invention is adapted herein to work in
conjunction with such a catheter and such a buffer amplifier, it
should be understood, and it is believed it will become apparent,
that the apparatus can easily be adapted for calibrating in
conjunction with other types of catheters and/or buffer amplifiers,
or like input devices.
Circuits 22, 24 are specially constructed in accordance with the
invention. Details of circuit 22 are shown in FIG. 2. This circuit
includes an oscillator 26, a current integrator 28, and an
attenuating and level-setting circuit 31. The oscillator, also
referred to as a first subcircuit, contains a conventional
integrated-circuit operational amplifier 30, connected with other
components in the circuit to perform as an oscillator with a
frequency of about 2 Hz., and a duty cycle of about 20%. More
specifically, connected between the output and the inverting input
of this amplifier is the parallel combination of an adjustable
resistor 32 and a pair of Zener diodes 34, 36 poled as indicated.
Connecting the inverting input to ground is a capacitor 38.
Further, the output of amplifier 30 is connected to ground through
the resistance element 40a of a potentiometer 40. The wiper 40b of
this potentiometer is connected to the noninverting input of
amplifier 30.
In oscillator 26, its frequency of oscillation is determined by the
relative values of the resistance of resistor 32 and the
capacitance of capacitor 38. Through adjusting the resistance value
of resistor 32, fine adjustments in the frequency of the oscillator
are possible. Duty cycle is controlled by the position of wiper 40b
on resistance element 40a. Diodes 34, 36 perform a clipping
function--preventing undesirable saturation in amplifier 30.
When operating, oscillator 26 generates a rectangular voltage wave
form such as wave form A in FIG. 4. Preferably, the oscillator is
adjusted so that this wave form has a frequency of about 2 Hz., and
a duty cycle of about 20%, with each positive pulse having a time
width (t.sub.1) of about 100 milliseconds, and with adjacent pulses
separated by about 400 milliseconds (t.sub.2). Wave form A may have
an overall amplitude of about 20 volts, although this is not at all
critical.
Integrator 28, also referred to as a second subcircuit, includes an
operational amplifier 42 which is substantially the same in
construction as amplifier 30. Connected as a feedback path between
the output and inverting input of amplifier 42 is the parallel
combination of a capacitor 44 and a pair of Zener diodes 46, 48
poled like diodes 34, 36. The noninverting input of the amplifier
is grounded. The wave form produced by oscillator 26 is fed to the
integrator through a dual-branch, parallel feeder circuit--one
branch of which includes an adjustable resistor 50 and a diode 52,
and the other branch of which includes a similar adjustable
resistor 54 and a diode 56. As can be seen, diodes 52, 56 are poled
in reverse directions, with diode 52 arranged to conduct away from
the oscillator, the diode 56 disposed to conduct toward the
oscillator.
In the integrator, diodes 46, 48 perform the same function as do
diodes 34, 36 in the oscillator. Capacitor 44 works with resistors
50, 54 to perform current integration.
Circuit 31 includes a pair of potentiometers 49, 51 whose wipers
49a, 51a are connected together through series resistors 53, 55.
One end of the resistance element 49b in potentiometer 49 is
connected to the output of amplifier 42, and the other end is
grounded. With respect to the resistance element 51b in
potentiometer 51, its upper end is connected to the positive
terminal of a suitable floating DC voltage supply, and its lower
end is connected to the negative terminal of the supply. The
junction between resistors 53, 55 connects with conductor 21.
The integrator receives wave form A, and, together with circuit 31,
produces a nonrectangular, monopolar wave form, such as that shown
at B in FIG. 4. It should be understood that the integrator alone
generates a wave form identical in configuration with wave form B,
but with a considerably larger overall amplitude. For example, the
actual wave form produced at the output of amplifier 42 might
typically have an overall amplitude of about 14 volts, whereas wave
form B preferably has an overall amplitude of about 150 millivolts.
Wiper 49a is adjusted to control the final overall amplitude of
wave form B, and wiper 51a is adjusted to assure that the lowest
voltage portions of this wave form are at ground potential.
As can be seen, each pulse in wave form B has a positively sloped
leading edge, a negatively sloped trailing edge, and a
substantially constant voltage portion between these edges. The
value of the positive slope of the leading edge is determined by
the relative values of the capacitance of capacitor 44 and the
resistance of resistor 50--the latter being adjustable to change
the value of this slope. Similarly, the value of the negative slope
of the trailing edge is determined by the capacitance of capacitor
44 and the resistance of resistor 54. Resistor 54 may be adjusted
to change the value of the slope.
Preferably, and as is in fact the case with wave form B, the
leading edge slope value is twice that of the trailing edge
slope--the former being about +3,000 millivolts/sec, and the latter
being about -1,500 millivolts/second. The leading edge extends over
about 50 milliseconds (t.sub.3), and the trailing edge extends over
about 100 milliseconds (t.sub.5)--these two slopes being separated
by the constant amplitude portion which lasts about 50 milliseconds
(t.sub.4). Such a shape is preferred, since it closely approximates
the actual shape of a typical voltage wave form generated by
devices such as a catheter 12 and buffer amplifier 16 when
following normal arterial blood pressure. Such a wave form is
illustrated at D in FIG. 4.
Adjustability of resistors 50, 54 is a very advantageous feature of
the integrator, since it permits accurate controlling of the slopes
mentioned.
FIG. 3 shows details of differentiating circuit 24. This circuit
includes a pair of operational amplifiers 58, 60 which are
essentially the same in construction as amplifiers 30, 42. The
noninverting inputs of both amplifiers are grounded. The inverting
input of amplifier 58 is connected to previously mentioned
conductor 27 through a resistor 62 in series with a capacitor 64.
Forming a feedback path between the output and the inverting input
of amplifier 58 is the parallel combination of a resistor 66 and a
capacitor 68. The output of amplifier 58 is coupled to the
inverting input of amplifier 60 through a resistor 70. An
adjustable resistor 72 is connected as a feedback path between the
output and the inverting input of amplifier 60. Amplifier 58, along
with resistors 62, 66 and capacitors 64, 68, performs signal
differentiation with respect to any signal supplied it via
conductor 27. Amplifier 60, along with resistors 70, 72, performs
as a low output impedance unity-gain amplifier.
When selector 18 is set to pass signals from circuit 22, wave form
B is supplied over conductor 27 to the differentiating circuit.
From this signal, the differentiating circuit produces bipolar wave
form C in FIG. 4 which it feeds to recorder 14. As will be noted,
for each pulse in wave form B, wave form C contains a pair of
pulses, the first one in time being positive, and the second one in
time being negative, The first, positive pulse lasts throughout the
duration of the leading edge of a pulse in wave form B. Its
amplitude is essentially constant, and directly reflects the value
of the slope of the leading edge. Similarly, the second, negative
pulse lasts throughout the duration of the trailing edge of the B
wave form pulse, having an amplitude directly reflecting the value
of the slope of the trailing edge.
With the leading edge having the slope value indicated, the
amplitude of the positive pulse in wave form C directly indicates
this value--i.e., +3,000 millivolts/sec. While the "absolute"
amplitude of the positive pulse is a matter of choice, resistor 72
herein is set to make this amplitude about +150 millivolts. With
such a setting, it will be apparent that each millivolt above or
below zero volts generated by the differentiating circuit
represents 20 millivolts/sec. slope value in wave form B. And,
since wave form B has been shaped like wave form D, and with about
the same overall amplitude, each millivolt from the differentiating
circuit can be directly interpreted as a change rate of 20 mm.
Hg/sec. of blood pressure.
The amplitude of the negative pulse in wave form C, of course, has
the same relationship to the slope of the trailing edge of a pulse
in wave form B.
When selector 18 is set to pass signals from buffer amplifier 16,
and assuming that catheter 12 senses normal bloodpressure changes,
differentiating circuit 24 feeds wave form E in FIG. 4 to recorder
14. It will be noted that above-described wave form C closely
approximates wave form E.
Explaining now the operation of system 10, under circumstances of
monitoring the arterial blood pressure of a patient, two wave forms
derived from catheter 12 are provided the two inputs of recorder
14. One of these wave forms-- that supplied via conductor 25, is a
voltage whose amplitude follows the actual instantaneous changes in
arterial pressure, with a change in pressure of 1 mm. Hg. producing
an actual voltage change of 1 millivolt in this wave form. The
other wave form, supplied the recorder via conductor 27, comprises
the differentiated form of what is supplied through conductor 25,
with a rate of blood-pressure change of 20 mm. Hg/sec. producing a
1 millivolt change in such wave form. Conductors 25, 29 are
referred to collectively herein as an output means.
It is naturally desirable that this information be accurately
recorded by the recorder in easily readable and interpretable form.
Circuits 22, 24 cooperate to calibrate the recorder to assure such
performance.
More specifically, to calibrate recorder 14, selector 18 is set to
pass signals from circuit 22 to amplifier 20. With circuit 22
adjusted as previously described to produce closely controlled wave
form B, this wave form passes through amplifier 20 (a unity-gain
amplifier), and over conductor 25, to the recorder, whereupon it is
recorded. Since it is known what the actual amplitude and shape of
wave form B is, it is a relatively simple matter for the operator
to adjust the usual sensitivity control associated with the input
connected to conductor 25, whereby to adjust the recorder to draw a
wave form having an actual amplitude in the drawing which can
easily be directly read in terms of actual blood pressure. In other
words, since it is known that the actual amplitude of wave form B
is 150 millivolts, and since it is known that this is related to
the expected performances of catheter 12 and amplifier 16 whereby
each millivolt represents 1 mm. Hg. of blood pressure, it should be
a simple matter to adjust the actual amplitude of the wave drawn by
the recorder so that it can easily be read off (on the usual
graph-like recorder paper) in terms of actual blood pressure.
Wave form B is also supplied to differentiating circuit 24. The
latter performs differentiation and supplies the first derivative
of wave form B to the other input in the recorder. The sensitivity
control associated with this input is then also adjusted to produce
a recorded drawing which can easily be read to indicate the rate of
blood-pressure changes.
With respect to the recording of wave form B, any appreciable
nonlinearity in the operation of the recorder's circuitry
associated with the input receiving this wave form will be
immediately apparent. The same is also true with respect to the
recording of wave form C. Here, the fact that there is a time
separation between the positive and negative pulses, resulting from
the presence of the constant amplitude portion in each pulse of
wave form B, greatly assists in determining the accuracy and
linearity of performance of the recorder. The actual time
separation used is not critical, so long as it is long enough to be
easily viewable in a recording of wave form C. A time separation of
as little as 1 millisecond, for example, has been found to be
usable. 50 milliseconds as used herein is very satisfactory, for it
clearly enables one to observe whether the monitoring device
accurately settles to a zero voltage level, as it should.
When these calibrating steps are complete, selector 18 may be set
to pass signals from catheter 12 and amplifier 16. Such information
is then fed directly over conductor 25 to the recorder, and in
differentiated form over conductor 29, to the recorder. And, after
the calibration described, a person using system 10 can accurately
read off blood pressure information directly from the recordings in
the recorder. Obviously, the calibration of the recorder can be
checked at any time simply by resetting selector 18 to couple
signals coming from circuit 22.
Thus, there is provided relatively simple and reliable circuitry
for producing a pair of carefully controlled signals which can be
used, as described, accurately to calibrate a blood pressure
monitoring instrument, such as recorder 14. By producing a wave
form B which closely approximates wave form D, and similarly, by
producing differentiated wave form C which is very much like
differentiated wave form E, calibration is possible under
circumstances subjecting a monitoring instrument to wave forms
essentially like that to be expected from normal arterial
blood-pressure changes. The adjustability provided in resistors 50,
54 in integrator 28 enables very close control over the slopes of
the leading and trailing edges mentioned in wave form B. This, of
course, is important in making wave forms B, C similar to wave
forms D, E, respectively. The fact that the overall amplitudes of
the wave forms produced by circuits 26, 28 are controlled by
clipping actions in the Zener diodes results in extremely good
amplitude stability with ambient temperature changes.
While a preferred embodiment of the invention has been described,
it is appreciated that variations and modifications may be made
without departing from the spirit of the invention.
* * * * *