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Claims  |
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What is claimed is:
1. Apparatus for producing information indicative of the mean blood
pressure of a living subject through indirect measurement comprising:
(a) inflatable, deflatable cuff means;
(b) pump means, connected to said cuff means, for inflating said cuff to a
pressure above systolic pressure of said subject;
(c) deflating means, connected to said cuff means, for controlled deflation
of said cuff means;
(d) means for measuring cuff pressure and, at a given cuff pressure,
pressure pulsations in said cuff means caused by heartbeats of said
subject;
(e) control means, responsive to said means for measuring, for initially
energizing said pump means to inflate said cuff, and for subsequently
energizing said deflating means incrementally to deflate said cuff at
predetermined pressure increments;
(f) wherein said measuring means includes:
(i) means for detecting, for each successive set of said pulsations
occasioned by successive heartbeats, pulsation amplitude and pulsation
time rate of change,
(ii) means for identifying, at each of said cuff pressure increments, the
occurrence of at least two successive sets of pulsations which meet
predetermined amplitude and time rate of change criteria relative to one
another,
(iii) means, responsive to said means for identifying, for energizing said
control means to deflate said cuff by an increment upon identification of
said occurrence of pulsations within said criteria, and
(iv) means, responsive to said means for identifying, for comparing
specified peak to peak amplitude factors of identified pulsations at
successive cuff pressure increments; and
(g) output means, responsive to said means for comparing, for indicating
mean blood pressure as the lowest cuff pressure increment corresponding to
the largest of said specified peak-to-peak amplitude factors.
2. An apparatus in accordance with claim 1 and further including adjustable
means for storing an upper limit and a lower limit for said mean arterial
pressure, means for comparing said upper limit and said lower limit with
the mean arterial pressure indicated by said output means, and alarm means
responsive to said comparing means for indicating occurrence of a measured
mean arterial pressure above said upper or below said lower limit.
3. An apparatus in accordance with claim 1 including means responsive to
said means for measuring for fully deflating said cuff means when said
cuff pressure has been reduced below a predetermined minimum.
4. An apparatus in accordance with claim 3 and further including counter
means, responsive to said means for measuring, for energizing said means
for deflating after a predetermined number of cuff pressure increments
following the measurement of said maximum peak-to-peak average value.
5. An apparatus in accordance with claim 3 and further including adjustable
time delay means for restarting the apparatus a predetermined time after
the most recent indication by said output means.
6. An apparatus in accordance with claim 3 including means for counting the
number of pressure pulsation signals occurring at each of said pressure
increments and for fully deflating said cuff means when the number of
pressure pulsation signals at said increment is in excess of a
predetermined maximum.
7. An apparatus in accordance with claim 1 including an overpressure switch
connected to said cuff means for actuating said deflating means to fully
deflate said cuff means when said cuff pressure is in excess of a
predetermined maximum.
8. An apparatus in accordance with claim 1 wherein said measuring means
includes a pressure transducer responsive to the pressure in said cuff
means to produce an output voltage signal representative of said cuff
pressure and said pressure pulsations.
9. An apparatus in accordance with claim 1 wherein said means for detecting
includes means for isolating fluctuating signal components from d.c.
signal components of said pulsations, and means for selectively processing
said components in digital fashion.
10. Apparatus as described in claim 1 wherein:
(a) said means for detecting includes means for evaluating the time
derivative of said pulsations;
(b) said means for identifying includes:
(i) means for comparing said time derivative with a predetermined
threshold,
(ii) means for detecting the pulsation peak next after said derivative
exceeds said threshold,
(iii) means for comparing successive ones of said detected pulsation peaks;
and
(c) said means for identifying includes means for averaging successive said
peaks which are within predetermined differentials of each other, to
produce an average peak value defining said amplitude factor.
11. Apparatus for producing information indicative of the mean blood
pressure of a living subject through indirect measurement comprising:
(a) inflatable, deflatable cuff means;
(b) pump means, connected to said cuff means, for inflating said cuff to a
pressure above systolic pressure of said subject;
(c) deflating means, connected to said cuff means, for controlled deflation
of said cuff means;
(d) means for measuring cuff pressure and, at a given cuff pressure,
pressure pulsations in said cuff means caused by heartbeats of said
subject;
(e) control means, responsive to said means for measuring, for initially
energizing said pump means to inflate said cuff, and for subsequently
energizing said deflating means incrementally to deflate said cuff at
predetermined pressure increments;
(f) wherein said measuring means includes:
(i) means for detecting, for each successive set of said pulsations
occasioned by successive heartbeats, pulsation amplitude,
(ii) means for identifying, at each of said cuff pressure increments, the
occurrence of at least two successive sets of pulsations which meet
predetermined amplitude criteria relative to one another,
(iii) means, responsive to said means for identifying, for energizing said
control means to deflate said cuff by an increment upon identification of
said occurrence of pulsations within said criteria, and
(iv) means, responsive to said means for identifying, for comparing
specified peak-to-peak amplitude factors of identified pulsations at
successive cuff pressure increments; and
(g) output means, responsive to said means for comparing, for indicating
mean blood pressure as the lowest cuff pressure increment corresponding to
the largest of said specified peak-to-peak amplitude factors. |
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Claims  |
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Description  |
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BACKGROUND OF THE INVENTION
The invention generally relates to pressure indicating devices of the type
used for the measurement of body fluid pressures and more particularly to
an indirect non-invasive automatic mean blood pressure reading device.
FIELD OF THE INVENTION
The pressures of fluids in the vessels of all living things are indications
of many facts which are of great value to those engaged in medical,
biological and related fields. In the case of humans, the pressure in the
vascular system is measured for many reasons, including diagnosis in
pathology, laboratory routine for certain ailments, ascertainment of the
progress of therapy, etc. As an example, the determination of venous blood
pressure is an essential element in the diagnosis of a patient suspected
of cardiac disease. Normal human venous blood pressure ranges between
80-120 millimeters water, whereas elevations of venous blood pressure
above that range are found in cases of congestive heart failure.
True mean arterial pressure is not the arithmetic average of the systolic
and diastolic pressure. Mean pressure depends on the amplitude and contour
of the arterial pressure wave. Thus for example, if a person has a
systolic pressure of 100 and a diastolic pressure of 50, the mean pressure
would not be 75 but would be closer to 63 because the pulsation of the
blood does not spend much time at the high systolic point as it retreats
quickly from this peak pressure so that most of the pulsation time is
spent at a lower pressure near the diastolic pressure. Thus if a total
arterial wave form is ascertained, or its mean, a better picture of the
patient's condition is presented to the physician. The presentation of
only the systolic and diastolic pressure to a physician does not enable
the physician to make a truly accurate assessment of the patient's
arterial wave form. All that is really indicated by the pressure is that
when the heart contracts, for some variable period of time the pressure in
the artery goes up to systolic pressure. Thus the physician cannot
determine if the pressure is for a tenth of a second, only that a
particular pressure has been reached for some unknown instant. However, as
to the actual pressure that the capillaries are encountering, the
fluctuations are all, or practically all damped out. Thus by knowing the
mean pressure the physician is better able to determine the pressure head
that is driving blood through the capillaries.
Oscillatory mean blood pressure measurement is discussed in the "The
Meaning of the Point of Maximum Oscillations in Cuff Pressure in the
Indirect Measurement of Blood Pressure" July-September 1969, the
Cardiovascular Research Center Bulletin page 15.
Presently the only means of measuring mean arterial pressure is to monitor
it with direct intra-arterial means. While doctors are presently taking
indirect measurements of the systolic and diastolic pressures of patients
there is currently no automatic way that indirect mean blood pressure
measurement can be obtained.
DESCRIPTION OF THE PRIOR ART
The most common method of obtaining indirect arterial blood pressure has
been to gradually apply constructive pressure about the limb of the
patient until the flow of blood through a vessel has been arrested, as
determined by listening to a stethoscope applied over the vessel at a
point distal the point of constriction. Then upon gradual release of the
constricted pressure, the beginning of the flow through the vessel can be
heard and the constricted pressure is noted on a gauge reading in
millimeters of mercury. This pressure is referred to as systolic pressure.
The pressure is then further gradually released until the sounds of the
flow again cease and the pressure is again noted, which pressure is
referred to as diastolic pressure. The difference between the diastolic
pressure and systolic pressure is termed pulse pressure. Previous
constriction pressure has been derived from an inflatable cuff connected
to a mercury column manometer or to an aneroid type gauge having a dial
scale calibrated in millimeters of mercury. While this common device is
satisfactory for measuring the diastolic-systolic pressure range for a
discrete period of time, it has the obvious disadvantage of not being able
to continuously monitor the patient's blood pressure.
Many other attempts have been made to devise indirect blood pressure gauges
which are portable, of reasonable cost and yet provide the attending
physician with an accurate determination of the patient's blood pressure.
One such device employs telescopically related, spring loaded tubes, the
tubes being biased in an extended position. By exerting axial pressure on
the tubes against an artery until blood flow in that artery is cut off,
and by monitoring the relative displacement of the tubes from the fully
extended position required to produce such flow cut off, the systolic
pressure is monitored. However, this means for monitoring the displacement
of the tubes is often inconvenient or clumsy.
Another prior art device employs a pointer extending from an inner tube
through a longitudinal slot in an outer tube, the outer tube having
calibrated markings adjacent the slot. A disadvantage with this
arrangement lies in the fact that the tubes, and hence the pointer, return
to the original biased position upon removal of the instrument from the
body, thereby requiring the operator to take a reading while exerting
direct pressure. Such a technique has been found to be inconvenient.
One automatic method which is used to obtain pressure readings comprises an
ultrasound transducer which emits an ultrasound beam toward the artery. If
the artery is pulsating, meaning that the pressure in the cuff is less
than systolic pressure, it reflects back some of the ultrasound at a
different frequency indicating that the pressure in the cuff must be below
systolic pressure. Thus by starting the pressure of the cuff far above
systolic pressure and bleeding it down slowly, one starts in a condition
where the reflected ultrasonic sound is not of a changed frequency, that
is the artery is not pulsating and as the cuff pressure bleeds down
further at a certain point the artery will begin to pulsate which is
indicated by a changed frequency. In the arterial pulsation method an
ultrasound pickup or a microphone or stethoscope can be used. In whatever
device is used, either ultrasound transducer or microphone, an instrument
is utilized external to the cuff thus requiring a wire connecting the cuff
to electronic circuitry used to make the pressure measurements.
There are several disadvantages in the above-mentioned types of devices,
one being that in the microphone and stethoscope devices the turbulence in
the flow of blood is heard rather than a change or a direct reflection of
pressure. What the device relies on is that the pressure in the cuff
occludes the flow of blood. Thus on the slow release of pressure the
resumption of flow is difficult to determine in low flow state such as
shock. In fact, in shock, the ausculatory method where one puts the
microphone or stethoscope over the artery and listens to the flow fails
because there is not enough flow to make Korotkoff noises. The ultrasound
method works better than the auscultatory method in shock because it
detects the movement of the artery rather than a flow within the artery.
The disadvantages in the ultrasound device however, are that the external
sensors must be closely and carefully applied over the artery and require
a coupling jelly which can be messy. Even if the transducers are
positioned very carefully, there is a possibility that they might shift
during a lengthy operation, resulting in erroneous readings or no readings
at all. Furthermore, the transducers are in an exposed position and can be
easily broken resulting in expensive replacement costs.
In addition, with the ultrasound equipment, if one wants to measure the
blood pressure of a child, a different size transducer must be used from
the transducer used to measure the blood pressure of an adult
necessitating the change of the transducer besides the additional cost of
purchasing the different size transducer.
Another indirect measuring device is shown in U.S. Pat. No. 3,903,872 which
teaches a system for measuring systolic and diastolic pressure by using a
blood pressure cuff with a transducer mounted on the outside of it. The
cuff is linearly inflated from zero pressure and during inflation the
device picks for diastolic pressure the cuff pressure at which the slope
of the first derivative just before the onset of a beat was a negative
maximum and chooses for systolic pressure a point of the cuff pressure at
which the second derivative was maximum.
Another indirect measuring method measures oscillation in the cuff
pressure. The method dates from the turn of the century but has not been
widely utilized because of the problems associated with it. It should be
noted that the indirect measurement of mean blood pressure in a horse has
been taken with the use of an oscillometer and a physiograph. This
indirect measurement is described in The Southwestern Veterinarian, Volume
23 Summer of 1970, number 4 pages 289-294 and appears to be the most
pertinent reference known to applicant in relation to the present
invention. In this publication the cuff pressure was recorded on the
physiograph and the oscillations in cuff pressure were amplified and
displayed by a rapid responding meter on an electronic oscillometer with
the amplified oscillations being recorded on the physiograph along with
the direct arterial pressures. This method of measuring mean pressure
requires operator judgment as to when the oscillations are maximum, which
is difficult to quickly and correctly ascertain.
SUMMARY OF THE INVENTION
The present invention relates to automatic indirect blood pressure reading
apparatus that automatically and adaptively pumps up an arm cuff to a
proper pressure by taking the previous cuff pressure measurement and
adding approximately 60 mm of mercury to the old pressure before beginning
measurement of the amplitude of the oscillations in the cuff.
This adaptive pump-up feature minimizes the period of time that blood flow
is occluded in the arm by minimizing the amount of overpressure required
to occlude.
Once the amplitude of the oscillations at the starting pressure are
measured the cuff is deflated a pre-determined pressure increment to a
lower pressure and the oscillations at this lower cuff pressure are then
measured. It is required that the pressure oscillations satisfy a
plurality of artifact detecting tests before a peak to peak oscillation
measurement is accepted as valid. Should an artifact be detected,
additional oscillations are measured until the oscillations are tested to
be free of artifacts. When this integrity test is satisfied or some
predetermined time interval is exceeded, the cuff is once again deflated a
pressure increment. The apparatus continues in this fashion until maximum
amplitude oscillations are obtained at the lowest cuff pressure which is
indicative of the mean arterial pressure. If after several deflation
cycles after the maximum oscillation is reached and no peak to peak
oscillation value is found which is greater than the peak to peak value
which was previously ascertained, the cuff pressure at which the
oscillations were maximum is displayed as mean arterial pressure and the
cuff is purged to allow the venous blood trapped in the arm to drain. A
programmed wait cycle is then entered and the entire procedure is repeated
at the end of the wait period.
The invention is an indirect and non-invasive automatic device that pumps a
cuff up and measures the mean blood pressure value automatically as it
automatically deflates in pressure increments without any operator
intervention. Additionally, it can be made to display a number
proportional to the magnitude of peripheral pulsation which can be useful
in determining the amount of vasoconstriction.
Measurement of mean arterial pressure by means of incremental deflation,
conditioned upon successfully passing a plurality of oscillation integrity
tests, forms a novel aspect of this invention and a desirable structure to
satisfactorily operate reliably without human intervention.
The invention is constructed with a pressure transducer, air-pump, deflate
valve, and a plurality of linear and digital semiconductor integrated
circuits positioned within a cabinet enclosure. A three digit, numerical
display indicates mean arterial pressure and an accessory printer can be
used to print a tape for a permanent record.
The above mentioned purposes and operation are more readily apparent when
read in conjunction with the following detailed description of a preferred
embodiment of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic block diagram of the overall invention.
FIG. 2 is a timing diagram of the cyclic action taken by the invention when
performing mean arterial pressure measurements automatically.
FIG. 3A is a timing diagram of the applied cuff pressure signal during
measurement.
FIG. 3B is a timing diagram of the arterial pulse pressure signal during
measurement.
FIG. 4A is a signal characteristic diagram showing a time sampled arterial
pulsation signal;
FIG. 4B is a signal characteristic diagram showing the derivative of the
signal of FIG. 4A;
FIG. 4C is a signal characteristic diagram of a sampled cuff pressure
signal taken simultaneously with the signals of FIGS. 4A and 4B;
FIG. 5 is a schematic block diagram of the pressure measurement circuits
shown in FIG. 1;
FIG. 6 discloses a block diagram of the peak to peak calculator with
artifact rejection circuits shown in FIG. 5;
FIG. 7A discloses the circuit operation of the pressure derivative
calculator of FIG. 6;
FIG. 7B discloses the circuit operation of the peak-to peak detector of
FIG. 6;
FIG. 7C discloses the circuit operation of the averager of FIG. 6;
FIG. 7D discloses the circuit operation of the amplitude check of FIG. 6;
FIG. 7E discloses the circuit operation of the envelope check of FIG. 6;
FIG. 7F discloses the circuit operation of the slope check of FIG. 6;
FIG. 7G discloses the circuit operation of the period check of FIG. 6;
FIG. 7H discloses the circuit operation of the rise time check of FIG. 6;
FIG. 7I discloses the circuit operation of the cuff pressure check of FIG.
6;
FIG. 8 is a block diagram of the maximum peak-to-peak selector circuit
operation of FIG. 5;
FIG. 9 is a schematic block diagram showing the adaptive pump-up circuit
operation of FIG. 5;
FIG. 10 is a schematic block diagram of the autozero pressure circuit
operation of FIG. 5; and
FIG. 11 is an electronic schematic showing implementation of a typical
sub-system of the invention using standard commonly available linear and
logic semiconductor circuit components.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The automatic mean arterial blood pressure measuring apparatus as shown in
FIG. 1 basically consists of an inflatable cuff 2 wrapped around an arm 1,
pump up and deflation means 7 and 9, and electronic pressure measurement
apparatus 6, 10, 11, 13, 14, 16 and 17 with numeric display means 23. With
the exception of the cuff all the component parts are housed within
cabinet 300. Additional circuits are provided to alert attending personnel
to abnormal pressure or operating conditions. Further patient safety is
enhanced with a protective overpressure switch 8 which will cause cuff
deflation should the pump fail to shut off in a normal, controlled manner.
The novelty of this invention primarily resides within the pressure
measurement circuits 11 combined with conditional, incremental cuff
deflation by means of deflate valve 7.
In operation, cuff 2 is wrapped around arm 1 and is automatically inflated
to a predetermined pressure via air-tube 4 by air-pump 9. A pressure
sensing tube 5 is connected to cuff 2 at point 3 and is coupled to an
electronic pressure transducer 6. This transducer outputs a voltage
proportional to the air pressure of tube 5 which typically consists of a
d.c. voltage with a small superimposed, variational component which is
caused by the arterial blood pressure pulsations in arm 1.
The transducer 6 produces an output 12 which is routed to a multiplexer 16
and to a bandpass filter 13 which in turn is connected to a
quasi-logarithmic amplifier and compressor 14, having an output signal 15
to multiplexer 16. Subsystems 13 and 14, namely the filter and amplifier
are designed to reject the d.c. component of pressure signal 12 and yet
amplify the blood pressure pulsations. The filter 13 passes those signals
whose frequency components lie in a range from 1 to 10 Hz and strongly
rejects other frequency components. Amplifier 14 magnifies low level
signals from filter 13 and reduces the level of larger signals in a manner
approximating that of a logarithmic curve. These components are not novel
and are readily implemented by one skilled in the art. The cuff pressure
signal 12 and pressure pulsation signal 15 will be further described in
the discussion of FIG. 3.
The multiplexer 16 selects one of two pressure signals and inputs it into a
sampling analog to digital convertor 17. Each sampled pressure point is
represented by 8 binary bits which are routed via line 18 to pressure
measurement circuits 11.
Circuits 11 employ a plurality of logic circuits to determine the minimum
cuff pressure for which a maximum pulsation exists. This cuff pressure
produces a signal output on connection 21 to display 23. Circuits 11 also
transmit a deflate control signal 34 to valve 7 via OR gate 39, a
multiplexer select signal 37 and a control signal 38 indicating to
apparatus timer 10 that a mean arterial pressure measurement is complete.
Also a power-on reset signal is transmitted from 20 to properly initiate
logic states when power from supply 19 is first turned on. Detailed
circuit operation of 11 will be described later.
As shown in FIG. 1, the MAPOUT signal 21 is also routed to comparators 27,
28 where the value is compared to the patient pre-determined acceptable
pressure limits as stored in counter/registers 24, 25 and found within
those limits. These limit values are set to desired values by switch 26
which causes the counters to up-count in steps of 5 mmHg. The stored limit
value is displayed by switch 22 which connects the display to either the
high or low limit registers. Should the measured means arterial pressure
be below the predetermined low-limit, then comparator 28 activates alarm
circuits 29 which generate an audible tone with sounder 30 and a visible
flashing light with light 31.
Another output signal transmitted from the measurement circuits 11 is the
MAPAV signal 38. This "mean-arterial-pressure-available" signal indicates
to the system operation timer 10 that a measurement is complete, and that
the timer may sequence to its next operation.
The operation timer 10 controls overall apparatus timing and is built with
conventional, logic integrated semiconductor circuits. It is constructed
with a crystal oscillator for precise timing and generates a plurality of
timing control signals. Output pulse "i" is the basic sampling pulse and
causes the A to D convertor 17 to take uniformly spaced samples. Output
pulse "n" exists each time a new pressure increment interval is to be
measured. The output pulse "n" is used by counting circuits in 11. Timing
signals "Tm" generated from timer 10 are used by the apparatus to operate
each separate operation and are shown in FIG. 2.
FIG. 2 is a diagram defining and summarizing each of four operation timing
intervals. T1 is the premeasurement interval lasting about 7 sec. in which
cuff 2 is stably deflated while display 23 continues to display the last
MAP reading. Circuits within 11 are enabled to automatically zero the
transducer 6 in case it has drifted. A detailed description of this
circuit will be given later.
T2 is the interval in which the air-pump 9 inflates cuff 2 to a value which
is adaptively set. The circuits and their operation for ascertaining this
value will be described later. The pump-up time is typically 5 sec.
Apparatus alarms 29, 30 and 31 are also used to alert attending personnel
to a possible failure. Should the sampling pulse "i" fail or MAPAV fail to
give a reading after 3 minutes, then the failsafe alarm 32 will activate
the alarms.
Operation timer 10, also has a control input from delay select switches 33
which are user selected for the desired interval between automatic
measurements.
T3, in FIG. 2, is the interval during which the cuff 2 is incrementally
deflated by valve 7 under control of the pressure measurement circuits 11.
The exact duration of this interval is dependent upon the quality of the
measured arterial heart pressure pulses. For example, if the patient
should be moving his arm or the attending surgeon should be bumping
against the cuff 2, then the artifact sensing circuits in 11 will reject
the affected pulsations and cease further cuff deflations until apparently
good pulsations are detected. Thus, the typical T3 interval is about 30
sec. but could extend to over a minute. Once circuit 11 has completed its
measurement, the MAPAV signal 38 advances the timer to interval T4, and
the new MAP is displayed on 23.
Interval T4 initiates cuff deflation and is followed by a period of
apparatus inactivity. The cuff is emptied quickly to minimize patient
discomfort. This idle interval is user settable with delay switches 33 for
0.5 to 8 minutes.
After interval T4, the apparatus repeats the described operations starting
again with interval T1.
A detailed description of the measurement circuits 11 requires some
definition of the basic pressure signals 12 and 15 (FIG. 1). Reference is
now made to FIG. 3A and 3B which shows typical behavior of the
cuff-pressure signal Pc(t) and the arterial pulsation signal p(t). During
a measurement interval, the cuff pressure is incrementally decreased
causing cuff pressure signal voltage 12 to proportionately decrease. Each
step n(50) and its successor (n+1) (51) is about 5 mmHg less. The arterial
pulsation signal 15 shows each pulse 52. This signal also shows the
deflate transient 53 which is ignored by logic in circuit 11 as will be
later described. Also shown is an artifact pulse 54 as might be caused by
someone hitting the cuff. Note that additional pulses 55 are measured
before another deflate is initiated. Arterial pulse pair 56 would be
decided by measurement logic circuits 11 to be the maximum peak-to-peak
arterial pulses according to circuits to be described. The corresponding
cuff pressure 57 would be decided to be the MAP 59 and displayed on
display 23. Once 5 deflations have been made beyond pulse point 56 or the
cuff pressure 12 is less than 20 mmHg., the cuff is deflated. This is
shown as point 58 on the cuff pressure signal.
The cuff and arterial pressure signals 12, 15, are digitized by convertor
17 and analyzed by circuits 11 (FIG. 1). Certain important digitized
signal characteristics are shown in FIG. 4. The sampled arterial pulse
waveform p(i), 60, has three important characteristics: 61 is its peak to
peak value PP(n) where n is the number of the current deflate interval; 62
is the duration between pulse peaks, Tpp, expressed in number of clock
samples, i; and 63 is the pulse rise time, Tr, also expressed as a number
of clock samples. These characteristics are derived by circuits in 11 with
aid of the signal derivative waveform 67. Details of this waveform (64,
65, 66) will be described later.
The corresponding typical sampled cuff pressure signal 68 is also shown,
and is used by a plurality of circuits in 11 in a manner which will be
described.
An expanded functional diagram of all the circuits contained within the
pressure measurement subsystem 11 is shown in FIG. 5. Most of these
circuit blocks will be further expanded to the detailed operating circuit
level in FIGS. 6 through 9.
The pressure measurement circuits subsystem contains circuits which are
operational during three timing intervals. During, T1, circuits 71 and 77
are activated to accomplish pressure transducer autozeroing. Basically,
source select circuit 74 connects the A to D signal 18 to differencing
amplifier 71 which transmits an output signal showing the difference
between a previously stored auto-zero pressure (Pco) and the new presumed
zero cuff pressure, Pc'(i) 84. Pco is adjusted by circuit 10 to force
Pc(i) 68 to be zero value in a manner to be described later. This "new"
Pco value is retained throughout the following T2, T3, and T4 intervals.
During interval T2, adaptive pump-up circuits 75 and 76 are activated and
line 18 is connected to 71. If a previous MAP value exists in storage
register 76, then circuits 75 enable the pump via line PMPON 36 to pump
until the cuff pressure is 60 mmHg over this previous MAP value. The
details of this will be discussed later on in the specification. When the
desired cuff pressure has been achieved as determined by measuring the
pressure on signal line 68, then the next timing cycle T3 is entered.
Signal T3 activates all of the measurement circuits during this interval
consisting of circuits 70, 71, 72,73, 80, 81, 82 and 83. Heartbeat counter
circuit 78 and cuff exhaust circuit 79 are ancillary safety circuits. The
basic operation of these circuits is as follows.
Circuit 70 calculates the average peak to peak value of the first two
arterial pulses in which no artifacts have been found. When the artifact
checks are found to be "all-okay" then the control line 86 sends the
average peak to peak pulse value to max. selector circuit 72. This
circuit, in turn, causes circuit 73 to store the corresponding cuff
pressure 68, if no previous stored peak-to-peak value was larger. On the
first step, the prestored value is always zero. The "all-okay" signal also
initiates a step deflate in cuff pressure via line 90 through gate 80 to
step-deflate circuit 81. Circuit 81 deflates cuff 2 via OR gate 82 with
control line 34 to a value 5 mmHg less pressure. The correct pressure is
measured with line 68. The timer 83 generates a "start" pulse 88 one-half
second after step deflate circuit 81 stops deflating as determined via
line 87, which delay permits the cuff pressure transient 53 (FIG. 3B) to
die away before starting another peak to peak measurement in 70. Start
pulse 88 initiates another measurement cycle at the lower cuff pressure.
This process continues until circuit 72 determines that it has
successfully selected the minimum cuff pressure in 73 for which the
average peak to peak pulsations 85 were a maximum. The details of this
selection are discussed later in the specification. The Mean Arterial
Pressure Available signal 38 is transmitted to the operation timer 10,
which advances the timer to state T4. Simultaneously, the "MAP OUT" signal
21 is sent to the display.
Safety circuit 78 is a simple logic counter which determines if the number
of heart pulses is in excess of fifteen during any pressure step which
only happens if no pulse pair is free of artifacts. Its output signal, 89,
initiates another cuff deflate via OR gate 80. By limiting the maximum
time the cuff pressure may dwell on any one increment, undue patient
discomfort is avoided.
The other safety circuit, 79, senses when cuff pressure has reached a
useful minimum of 20 mmHg pressure and then initiates a full cuff deflate
via gate 82.
An important and novel feature of this invention is the incorporation of
sophisticated artifact detection circuits which are incorporated in
pressure calculator 70 and shown in more detail in FIG. 6. The peak to
peak calculator consists of circuits 100, 101, and 104. Peak to peak
detector 100 determines the difference in value between the pulse maximum
and base of the pulse wave form where the positive slope first exceeds a
predetermined threshold as was shown in FIG. 4. This value is found for
two successive arterial pulses and averaged by circuit 101. This average
peak to peak value PP(n) is transmitted on line 85.
Artifact detection circuits 102, 103, 105, 106, 107 and 108 have their
signal outputs AND'ed by gate 109. Only if all of these circuits are
satisfied to be artifact free is the "All-okay" line 86 enabled on this
subsystem output. Should an artifact be detected, inverter circuit 101
enables 0.5 second timer 111, which in turn causes all of the peak to peak
calculator circuits to take additional pulse pair measurements without
another cuff deflate. The 0.5 second delay gives time for the artifact
transients to die out in the pneumatic system (2,4,5,6). The peak to peak
calculator and artifact rejection circuits as described in FIG. 6 are seen
to embody three principles vital to the reliable determination of
non-invasive mean arterial blood pressure by automatic means: (1)
determining peak to peak heart pulse value by analysis of its time
derivative (described in detail in FIGS. 7A and 7B), (2) performing an
average operation on a plurality of arterial pulses (described in detail
in FIG. 7C), and (3) not permitting another incremental cuff deflation
until at least a pair of heart pulses successfully pass a plurality of
artifact sensing tests. These artifact sensing tests are described in
detail in FIGS. 7D, E, F, G, H, and I.
The time derivative of the heart pulse signal p(i) is calculated to aid the
peak to peak detector and artifact sensing circuits. The derivative
calculator 104 is shown in detail in FIG. 7A. The detail shown in this
figure and the remaining figures is sufficiently detailed so that they are
readily implementable with commercially available logic circuits by one
skilled in the art of electronics design. The derivative calculator 104
simply calculates the difference between the current pressure pulse value
6 and its previous value. The difference is transmitted as an output
signal as the derivative 201.
This value is used by peak to peak detector 100 as shown in FIG. 7B. The
first circuit 202, compares the derivative 201 to a predetermined value
"L1". When L1 is exceeded in value by 201, then the previous pressure
sample p(i-1) is stored as the minimum value of the heart pressure pulse
"Pmin." The maximum value of the pulse is then determined as the p(i)
value where the derivative is below a threshold value "L2" which is near
zero. The corresponding p(i) value is stored as Pmax by circuit 203.
Circuit 204 calculates the peak to peak value as Pmax-Pmin and outputs it
as signal 205, PP(a). A second pulse is similarly found, PP(b), and
transmitted on line 205 to averager circuit 101. The relative relationship
of thresholds L1 and L2 are easily seen in FIG. 4B. The important and
novel feature about this peak to peak calculation is that the minimum of
the pulse is measured at the base of the heart systolic pulse rather than
the diastolic transient minimum (see FIG. 4B, 206). This technique has
been found to yield more accurate MAP measurements with less variance when
compared to direct, invasive pressure measurements.
Averaging circuit 101 as shown in FIG. 7C sums PP(a) and PP(b) and divides
them by 2. The previous value is stored in register 208 and the new
average is transmitted as output signal 85. The averager circuit provides
immunity to high frequency, low-level pressure artifacts.
The amplitude check circuit 102 is shown in FIG. 7D. The two adjacent peak
to peak values PP(a), PP(b) output signals by the peak to peak detector
100 are compared in amplitude. If the second value differs by less than
20% of the first value, then the check is satisfactory and a binary signal
output one is transmitted; otherwise the output is a binary zero. Circuit
102 is effective at detecting pressure artifacts such as attending
personnel hitting the cuff accidentally in synchronism with the arterial
pulses.
The purpose of this tolerance requirement is to reject those beats which
are widely variable in amplitude from beat to beat such as could be caused
by premature ventricular contractions. Not only does this eliminate the
acceptance of variable data during heartbeat irregularities but it also is
quite useful for reducing the influence of pulsation artifacts caused by
subject motion or outside interference such as the physician bumping
against the cuff as could occur in an operation.
Should two artifact pressure pulses be caused of approximately the same
amplitude, such that it would satisfy the test of circuit 102, another
amplitude test is made by circuit 103 shown in detail in FIG. 7E. This
circuit compares the envelope, that is, the calculated average peak to
peak heart pulses PP(n), 85, with the previously calculated value of the
previous cuff pressure increment. As shown in FIG. 7E, the absolute
difference of these average peak to peak values must be less than 30% of
their sum to pass the test. As was shown earlier in FIG. 3, the heart
pressure peak to peak amplitudes change gradually between cuff deflation
increments and the comparator 216 and register 215 of circuit 103 will
detect violations of this rule.
Another artifact detecting circuit 105, FIG. 7F, determines if the heart
pulse derivative 201 ever exceeds a predetermined limit L6. Since the
human heart cannot increase arterial pressure faster than some maximum,
this circuit tests to see if that maximum is exceeded due to any artifact.
If this test is passed, output signal 220 is a binary one. Otherwise it is
a binary zero. The relative value of this limit L6 is shown in FIG. 4B.
An additional artifact detecting circuit 106 tests the heart pulse period
(Tpp, 62 of FIG. 4A) of the heart pulse pair and compares it to the
previously measured heart pulse pair period during the previous cuff
deflation increment interval. This circuit is shown in FIG. 7G. Circuit
221 determines the sample number of the first heart pulse maximum and
circuit 222 does the same on the second heart pulse. Subtractor 223
calculates the peak to peak time period Tpp as the difference of these
sample clock values. Time period Tpp is then compared in circuit 225 with
the previous Tpp 224 and if they are equal within a 15% tolerance, then
the test is satisfied. This test is disabled during the first pressure
deflation so that the "previous value" may be stored.
The time period checking circuit is a valuable artifact detecting circuit
because erroneous arterial pulses which may pass the aforementioned
amplitude tests are unlikely to also have precise periodicity.
This relative immunity to artifact is enhanced by several additional
criteria which must be met by the pulsations before they are accepted by
the device as being true cuff pressure pulsations due to heart action. One
criteria is that the rate of pulse rise be within a certain range. That
is, if the rate of rise of a pulsation is either too slow (as could be
caused by a gentle pressure applied from without or within the cuff) or if
the rate of rise is too fast (as could be caused by someone striking the
cuff) the pulsation will be disregarded regardless of its amplitude.
Such an artifact sensing test is made by circuit 107 by confirming that the
heart pulse rise time is within prespecified limits. FIG. 7H shows that
this is accomplished by taking the time difference (expressed as number of
sample periods) between the base of the heart pulse and its maximum (see
63 on FIG. 4B). Circuit 230 in FIG. 7H stores the sample clock value, i,
where the pressure derivative 201 first exceeds a pre-determined
threshold, L1. Circuit 231 similarly stores the "i" value when the
derivative is below another threshold (near zero) L2. FIG. 4B shows the
relative values of these two thresholds. Circuit 232 determines the
rise-time as the difference of the output signal 230 and 231 and circuit
233 compares this rise time value to two predetermined values. If rise
time 63 is between these two limits, circuit 233 produces a binary one
output signal; otherwise, the output is a zero. This test is valuable at
detecting any artifacts which may have periodic, consistent pressure
amplitudes, thus passing aforementioned tests, but which are rapidly or
very slowly applied to the cuff.
In order to insure that the mean cuff pressure has not varied significantly
during these tests at any given deflation increment, a continuous check is
made by circuit 108 and is shown in detail in FIG. | | |