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Systolic pressure determining apparatus and process using integration to determine pulse amplitude    
United States Patent4137907   
Link to this pagehttp://www.wikipatents.com/4137907.html
Inventor(s)Jansen; William D. (Palo Alto, CA); Haney; Jerry D. (Sunnyvale, CA); Day; Christopher C. (Newtonville, MA); Schneeberger; Stephen A. (West Hartford, CT)
AbstractImproved method and apparatus for identifying and quantizing a substantially periodic, steeply rising wavefront of a signal in the possible presence of low amplitude interference. A time derivative of at least the steep wavefront is obtained. The derivative is then integrated over a predetermined interval in each of successive repetitions of the steep wavefront, the interval being that during which the derivative exceeds a reference level. A threshold value is established, preferably dynamically, to verify or validate that when the derivative exceeds the reference level it indeed represents the steeply rising wavefront. The integrated derivative is recognized as the quantized value of the steeply rising wavefront only if such verification occurs. The invention is suited to oscillometric determination of systolic pressure in a patient, where measurement of signal amplitude is preferably achieved by integrating the time derivative of the systolic rise wavefront.
   














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Drawing from US Patent 4137907
Systolic pressure determining apparatus and process using integration to

     determine pulse amplitude - US Patent 4137907 Drawing
Systolic pressure determining apparatus and process using integration to determine pulse amplitude
Inventor     Jansen; William D. (Palo Alto, CA); Haney; Jerry D. (Sunnyvale, CA); Day; Christopher C. (Newtonville, MA); Schneeberger; Stephen A. (West Hartford, CT)
Owner/Assignee     American Optical Corporation (Southbridge, MA)
Patent assignment
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Publication Date     February 6, 1979
Application Number     05/754,387
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     December 27, 1976
US Classification     600/494
Int'l Classification     A61B 005/02 2.05 Q 2.05 Z
Examiner     Michell; Robert W.
Assistant Examiner     Jaworski; Francis J.
Attorney/Law Firm     Duggan; Jeremiah J. Schneeberger; Stephen A. ,
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Parent Case    
Priority Data    
USPTO Field of Search     128/2.05 A 128/2.05 C 128/2.05 D 128/2.05 E 128/2.05 G 128/2.05 F 128/2.05 M 128/2.05 S 128/2.05 P 128/2.05 V
Patent Tags     systolic pressure determining integration to determine pulse amplitude
   
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ReferenceRelevancyCommentsReferenceRelevancyComments
4035622
Obermajer
600/526
Jul,1977

[0 after 0 votes]
4009709
Link
600/494
Mar,1977

[0 after 0 votes]
3996925
Djordjevich
600/506
Dec,1976

[0 after 0 votes]
3878833
Arneson
600/485
Apr,1975

[0 after 0 votes]
3835840
Mount
600/506
Sep,1974

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3590811
Harris
128/892
Jul,1971

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We claim:

1. Apparatus for determining systolic pressure of a living test subject comprising means for applying a selectively changeable pressure to the test subject adjacent a blood vessel; means for measuring a fluctuating quantity proportional to a sum, said sum comprising a time-dependent fluctuating component proportional to the amplitude of the pulsatile pressure within the blood vessel plus the selectively changeable pressure applied externally adjacent the blood vessel; means for converting said quantity into a representation of a time derivative of said fluctuating component thereof; means for obtaining the time integral of said time derivative over an interval of predetermined limits in each of successive blood pressure pulses, said interval being the time during which said time derivative representation exceeds a predetermined reference level; means for determining the maximum value attained by successive said integrals as the applied pressure is changed; means for storing a representation of said maximum integral value; means for determining when a said integral is substantially equal to a predetermined fraction of said maximum integral value for an applied pressure greater than the pressure applied when said maximum integral value results; means for reading out said applied pressure corresponding to said integral being substantially equal to said predetermined fraction to said maximum value, said read-out pressure corresponding to the systolic pressure of said subject; means for establishing a threshold level signal representative of the magnitude of substantially only the time derivative representing a systolic rise; means for comparing said time derivative representation of said fluctuating component of said quantity with said threshold level signal while said time derivative representation exceeds said reference level to provide a control signal indicative of whether or not said time derivative representation exceeding said reference level is representative of a valid systolic rise; and means responsive only to a validating indication that a particular said time derivative representation exceeding said reference level is a systolic rise for extending said integral of said particular representation to said maximum integral value determining means and said fraction of maximum integral value determining means.

2. The apparatus of claim 1 wherein said input signal is additionally in the possible presence of high amplitude, low frequency interference and wherein said time derivative means comprises a differentiating network for converting said input signal into a representation of the first time derivative thereof over a frequency band including said steeply rising wavefront and into a representation of the second time derivative thereof at the lower frequency of said possible high amplitude, low frequency interference.

3. The apparatus of claim 1 wherein said threshold level signal establishing means establishes said threshold level as a function of the magnitude by which at least the immediately preceding time derivative representation exceeding said reference level exceeds another reference level.

4. The apparatus of claim 3 wherein said reference level and said other reference level are the same.

5. The apparatus of claim 4 wherein said threshold level is proportional only to the magnitude by which said immediately preceding time derivative representation exceeds said reference level.

6. The apparatus of claim 5 wherein said threshold level is substantially 50% of said reference-exceeding magnitude of said immediately preceding time derivative representation.

7. The apparatus of claim 6 wherein said means for obtaining the time integral of said time derivative representation comprises accumulating means, said time derivative representation being subdivided into successive subinterval increments applied to and accumulated in said accumulating means during each interval in which it exceeds said reference level, the accumulated value of said subinterval increments for each said reference-level-exceeding interval comprising a respective tentative said integral, said systolic rise validating means being operative to extend only said integrals attending respective valid systolic rises to said maximum integral value determining means.

8. The apparatus of claim 6 wherein said means for obtaining the time integral of said time derivative representation comprises accumulating means, means for temporarily storing that portion of said time derivative representation extending over an immediately preceding interval, said immediately preceding interval being at least as long as the maximum anticipated duration of the systolic rise portion of the blood pressure pulses, means responsive to said time derivative representation going from a level exceeding said reference level to a level not exceeding said reference level and responsive to an indication of valid systolic rise from said validating means for directing a last in-first out readout of said portion of said time derivative representation stored in said storage means, means for extending said readout from said storage means to said accumulating means and for accumulating only those values of said readout which exceed said reference level, the value of said time derivative representation readout accumulated by said accumulating means being extended to said maximum integral value determining means.

9. The apparatus of claim 1 wherein said means for obtaining the time integral of said time derivative representation comprises accumulating means, said time derivative representation being applied to and accumulated in said accumulating means during each interval in which it exceeds said reference level, the accumulated value of each said reference-level-exceeding intervals comprising a respective tentative said integral, said systolic rise validating means being operative to extend only said integrals attending respective valid systolic rises to said maximum integral value determining means.

10. The apparatus of claim 9 including means for clearing said accumulating means prior to each subsequent integrating accumulation.

11. The apparatus of claim 9 including means for converting at least said reference-level-exceeding portions of said time derivative representation to consecutively timed discrete increments thereof and wherein said accumulating means sum said discrete increments which exceed said reference level.

12. The apparatus of claim 1 wherein said means for obtaining the time integral of said time derivative representation comprises accumulating means, means for temporarily storing that portion of said time derivative representation extending over an immediately preceding interval, said immediately preceding interval being at least as long as the maximum anticipated duration of the systolic rise portion of the blood pressure pulses, means responsive to said time derivative representation going from a level exceeding said reference level to a level not exceeding said reference level and responsive to an indication of valid systolic rise from said validating means for directing a last in-first out readout of said portion of said time derivative representation stored in said storage means, means for extending said readout from said storage means to said accumulating means and for accumulating only those values of said readout which exceed said reference level, the value of said time derivative representation readout accumulated by said accumulating means being extended to said maximum integral value determining means.

13. The apparatus of claim 12 including means for clearing said accumulating means prior to each subsequent integrating accumulation.

14. A method for determining blood pressure of a living test subject comprising:

applying a selectively changeable pressure to the test subject adjacent a blood vessel;

measuring a quantity proportional to a sum, the sum comprising a time-dependent fluctuating component proportional to the amplitude of the pulsatile pressure within the blood vessel plus the selectively changeable pressure applied externally adjacent the blood vessel;

converting said quantity into a representation of the time derivative of the fluctuating component thereof, a portion of the time derivative in each of successive blood pressure pulses being representative of the systolic rise;

determining the time integral of said time derivative over an interval of predetermined limits in each of successive blood pressure pulses as a measure of this systolic rise, said interval being the time during which said time derivative representation exceeds a predetermined reference level;

establishing a threshold level signal representative of the magnitude of substantially only the time derivative representation of a systolic rise;

comparing said time derivative representation of said fluctuating component of said quantity with said threshold level signal while the time derivative representation exceeds said reference level to provide a control signal indicative of whether or not said time derivative representation exceeding said reference level is representative of a valid systolic rise;

processing selective ones of said time integral to provide an indication of blood pressure; and

selecting for processing only the said time interval of said time derivative representations indicated as being valid systolic rises.
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BACKGROUND OF THE INVENTION

The present invention relates generally to waveform analysis, a particular application of such waveform analysis being in the field of blood pressure monitoring, particularly as relates to automatic monitoring of systolic blood pressure.

The prior art is replete with devices for measuring systolic pressure of a living subject. An old and simple device is a pressurizeable cuff used in combination with a mercury manometer which reads pressure in the cuff and a stethoscope which is used to listen to Korotkof sounds. In another advanced method of measuring blood pressure, the distance from a blood pressure cuff to the wall of an artery is accurately determined by measuring Doppler shifts of sound waves reflected by the artery. In yet other methods for measuring blood pressure intrusive devices are often inserted directly into blood vessels.

Oscillometric methods of determining systolic pressure are also well known in the art. In such methods, the operator observes the representation of the strength of pulsations of pressure within an artery. This can be done visually, as by watching the extent of bouncing at the top of a mercury column in a mercury manometer which is in pressure communication with the cuff or indirectly as by measuring the occlusion which occurs to a blood vessel in the pinna of the ear as pressure is exerted thereon. These oscillometric methods generally define systolic pressure to be the maximum applied pressure with which threshold oscillations are observed to occur. With a typical mercury manometer and pressurized cuff, this pressure would then be the highest pressure which the operator noted bouncing on the top of the mercury column as the pressure in the cuff was slowly and relatively uniformly reduced. However there are inaccuracies associated with this method for determining threshold oscillations, since the inertia of the mercury column does not allow it to noticeably respond to narrow width pressure pulses.

Each of the aforementioned techniques or devices for measuring systolic pressure exhibit some form of shortcoming such as inaccurate response to narrow width pressure pulses or the requirement for sophisticated and/or expensive measuring equipment.

There is described in U.S. Patent application Ser. No. 578,047, filed May 15, 1975 by Link et al for Apparatus and Process for Determining Systolic Pressure, assigned to the present assignee and incorporated herein by reference, a method and apparatus for automatically and relatively simply obtaining accurate systolic blood pressure measurements, thereby overcoming the shortcomings of the aforementioned devices. That device determines systolic pressure by applying pressure to a living test subject by changing pressure in a pressure cuff attached to the subject adjacent a blood vessel; by measuring at the cuff a quantity proportional to a time dependent fluctuating component representative of the pulsatile pressure within the blood vessel, which quantity is proportional to the amplitude of the pulsatile pressure; by determining the maximum value attained by the quantity as the applied pressure is changed; by storing a representation of the maximum value; by determining when the quantity is substantially equal to about one half of the maximum value for an applied pressure greater than the pressure applied when the maximum value occurs or results; and by reading out the applied pressure corresponding to the quantity being substantially equal to about one half of the maximum value, the readout pressure corresponding to the systolic pressure of the subject. The signal from the pressure cuff comprises a fluctuating quantity proportional to a sum, that sum comprising a time dependent fluctuating component proportional to the amplitude of the pulsatile pressure within the blood vessel, which component has a steeply rising wavefront between end diastole and systole, plus the selectively changeable pressure applied externally adjacent the blood vessel by the cuff.

In U.S. Patent application Ser. No. 754,201 by J. D. Haney and W. Jansen for Systolic Pressure Determining Apparatus and Process Using Integration to Determine Pulse Amplitude, filed Dec. 27, 1976, there is described a systolic blood pressure monitor of the general type described in the aforementioned U.S. patent application Ser. No. 578,047 and being improved in a manner assuring increased accuracy in the determination of systolic blood pressure. The improved monitor does not use a peak-to-peak detector for determining the amplitude of the steeply rising wavefront of the fluctuating component of the signal from the cuff, but instead, differentiates the cuff signal to obtain the time derivative of the fluctuating component, and then integrates a portion of the derivative.

The time derivative signal extends above a zero reference level from the time of end diastole through systolic rise to the systolic peak. Thus, the "above 0" area under the time derivative waveform is representative of the peak-to-peak magnitude (diastolic-to-systolic) of a respective blood pressure pulse. By integrating the "above 0" portion of the time derivative waveform an integral value is obtained which is proportional to the area under the waveform and, accordingly, is representative of the peak-to-peak magnitude of the blood pressure pulse. This integral value is then available for use on a beat-to-beat basis for determining the maximum value attained by the fluctuating component from the cuff and later determining one half of that maximum value in the determination of systolic pressure.

In the apparatus of the aforementioned application U.S. Ser. No. 754,201 by Haney and Jansen, the integration of the time derivative waveform was delimited by the positive-going crossing of the zero reference at the beginning and the negative-going crossing of the zero reference at the end. However, certain artifacts in the cuff signal during the diastolic drop, such as due to patient movement, may result in the time derivative waveform exceeding the zero reference for a brief time other than between end diastole and the systolic peak. Although generally much smaller in magnitude than the "above 0" passage of the signal derivative during systolic rise, this otherwise superfluous "above 0" passage of the artifact time derivative may be included in the determination of an integral value for use in the beat-to-beat determination of that peak-to-peak value representative of one half of the maximum peak-to-peak value, and thereby impair the accuracy of the systolic pressure determination.

SUMMARY OF THE INVENTION

In its broadest sense, the invention comprises an improved means and method for identifying and quantizing an essentially periodic, steeply rising wavefront of an input signal in the possible presence of low amplitude interference, and possibly also high amplitude low frequency interference signals. Such improved apparatus comprises means for obtaining a representation of the time derivative of at least the steeply rising wavefront portion of the input signal; means for obtaining the time integral of the time derivative representation over an interval of predetermined limits in each of successive repetitions of the steeply rising wavefront, the interval being the time during which the time derivative represntation exceeds a predetermined reference level; means for establishing a threshold level signal representative of the magnitude of substantially only the time derivative representing the steeply rising wavefront; means for comparing the time derivative representation of the input signal with the threshold level signal while the time derivative representation exceeds the reference level to provide a control signal indicative of whether or not the time derivative representation exceeding the reference level is representative of a valid steeply rising wavefront; and means responsive only to a validating indication that a particular time derivative representation exceeding the reference level is a valid steeply rising wavefront for recognizing the respective integral of the particular time derivative representation as the quantized value of the steeply rising wavefront.

The method of the invention comprises converting the input signal into a representation of a time derivative of at least a steeply rising wavefront portion of the input signal; determining the time integral of the time derivative representation over an interval of predetermined limits in each of successive representations of the steeply rising wavefront, the interval being the time during which the time derivative representation exceeds a predetermined reference level; establishing a threshold level signal representative of the magnitude of substantially only the time derivative representing the steeply rising wavefront; comparing the time derivative representation of the input signal with the threshold level signal while the time derivative representation exceeds the reference level to provide a control signal indicative of whether or not the time derivative representation exceeding the reference level is representative of a valid steeply rising wavefront; and recognizing as the quantized values of the respective steeply rising wavefront only the respective integrals receiving a validating indication.

The method and apparatus of the invention additionally provide for establishing the threshold level signal as a function of the magnitude by which at least the immediately preceding time derivative representation exceeding said reference level exceeds another reference level, that other reference level normally being a zero reference and the same as said reference level.

The method and apparatus of the invention additionally provide for doubly differentiating the input signal in a low-frequency range to alternate high amplitude, low-frequency components.

In one embodiment of the invention, the method and apparatus provide for integrating the time derivative representation in accumulating means whenever the representation exceeds the reference level, and to then recognize as a valid integral value only that integral obtained during an interval in which the time derivative representation at some time exceeded the threshold level.

In another embodiment of the method and apparatus of the invention, an immediately preceding portion of the time derivative representation having a duration at least as long as the maximum anticipated duration of the rise of the steeply rising wavefront is temporarily stored. When the time derivative representation crosses the reference in the negative going direction and a determination has been made that the representation had exceeded the threshold level during the immediately preceding "above 0" passage, the stored representation is then read out of storage in a last in-first out sequence and the "above 0" portion thereof is integrated in accumulating means to form the requisite integral value.

The apparatus of the invention finds particular utility in blood pressure monitoring equipment wherein it is desired to know the peak-to-peak value of each blood pressure pulse across the systolic rise (steeply rising wavefront) from end diastole to systole. Such knowledge of the peak-to-peak value of each blood pressure pulse it utilized in a preferred embodiment for determining the systolic pressure of a living test subject. The input signal may be obtained from a pressure cuff or other means. Means are provided for determining the maximum value attained by successive recognized (i.e. valid) integral values, which values correspond with the peak-to-peak value of the respective pulses. The maximum determined integral value is stored and means are provided for determining when a said integral value is substantially equal to about one half of the maximum integral for an applied pressure greater than the pressure applied by the cuff when the maximum integral value results, the applied pressure at which that particular one half maximum integral value occurs being read out as the systolic pressure.

It is a principal object of the present invention to provide an improved apparatus and process/method for identifying and quantizing an essentially periodic, steeply rising wavefront in the presence, or possible presence, of low amplitude interference, and possibly also high amplitude, low frequency interference.

It is another object of the present invention to provide an improved apparatus and process/method for determining systolic pressure. Included in this object is the provision of an improved apparatus and process/method which determines systolic pressure in a manner which reduces the possibility of false readings and thereby increases accuracy.

These and other objects and advantages of the present invention will be apparent to those skilled in the art after referral to the detailed description of the preferred embodiments in conjunction with the appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a prior art technique for the determination of the peak-to-peak magnitude of the pulsatile pressure within a blood vessel;

FIG. 2 illustrates a technique for the determination of peak-to-peak amplitude of the pulsatile pressure in accordance with the invention;

FIG. 3A illustrates a typical oscillometric envelope of the pulsatile pressure of a blood vessel;

FIG. 3B illustrates the time derivative of the FIG. 3A waveform;

FIG. 3C illustrates a controlled mode timing diagram in accordance with the basic method and apparatus of the invention;

FIG. 3D illustrates the time intervals obtained from the waveform of FIG. 3B in accordance with the basic apparatus and process of the invention;

FIG. 4 illustrates, in a block diagram, the apparatus and process of one embodiment of the invention;

FIG. 5 illustrates a plot of the gain vs. frequency characteristics of a differentiating network employed in a preferred embodiment of the invention;

FIG. 6A represents an enlarged portion of the time derivative waveform illustrated in FIG. 3B showing a validation threshold level and the timing of various control states associated therewith in accordance with the embodiment illustrated in FIG. 4;

FIG. 6B illustrates a control state diagram in accordance with FIG. 6A and the embodiment of FIG. 4;

FIG. 7 illustrates a flow chart or decision tree of the control sequence employed by the embodiment illustrated in FIG. 4 between successive heart beats;

FIG. 8 illustrates, in an abbreviated block diagram supplemented by FIG. 4, the apparatus and process of another embodiment of the invention; and

FIG. 9 illustrates a technique similar to that of FIG. 2 for the determination of peak-to-peak amplitude of the pulsatile pressure and further including threshold detection means for identifying particular "above zero" passages of the waveform derivative as valid systolic rises.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring first to FIG. 1, there is illustrated a functional block diagram of certain portions of the systolic pressure measuring apparatus described in the aforementioned application U.S. Ser. No. 578,047. More specifically, the functional blocks of FIG. 1 illustrate a filter network 100 having its output connected through amplifier 102 to the input of a peak-to-peak detector 104. Filter network 100 receives an input signal 106a on input conductor 106. The input signal 106a comprises a slowly-increasing ramp indicative of the applied cuff pressure and having superimposed thereon the time-dependent fluctuating component representative of pulsatile pressure within the blood vessel of the subject, which component representative of pulsatile pressure has a steeply rising wavefront relative to the remaining components during the rise from end diastole to systole. Filter network 100 was typically constructed such that its output waveform 100a had the linear effects of the pressure ramp removed therefrom, however, any random and uncontrollable deviation from the presumed linearity of the pressure ramp would introduce errors in the signal 100a. For instance, if a large perturbation in the cuff pressure ramp was encountered, filter 100 required a considerable time to recover and could allow some variation in the base line 100b (dotted) from which the fluctuating signal proportional to the amplitude of the pulsatile pressure within the blood vessel w as measured. Accordingly, each time peak-to-peak detector 104 is operated in response to sampling signals 108, the resulting output signal 110a appearing on conductor 110 included those peak-to-peak errors introduced by the variation in base line 100b.

In accordance with the present invention as illustrated generally in FIG. 2, an input signal 206a having a waveform identical to that of waveform 106a in FIG. 1 is applied to the input conductor 206 to differentiating network 200. Differentiating network 200 is constructed such that it provides single differentiation of signal 206a over that range of frequencies corresponding with the frequencies of the fluctuating signal proportional to the amplitude of the pulsatile pressure within the blood vessel, and doubly differentiates the input signal below that range of frequencies in order to remove the offset effects of a linear pressure ramp and any very low frequency perturbations which might have appeared in the otherwise linear pressure ramp.

A filter or differentiating network having the properties required of network 200 will possess the Gain v. Frequency characteristics illustrated in FIG. 5 in which the Gain curve exhibits a -6db per octave slope in the frequency range f.sub.1 -f.sub.2 and a -12db slope for frequencies below f.sub.1. The frequency range f.sub.1 -f.sub.2 corresponds with the bandwidth of the P.sub.ac signal comprising the fluctuating quantity representative of the pulsatile pressure. Frequency f.sub.1 may be about 0.05-0.1 Hz and f.sub.2 may be about 10-20 Hz. Network 200 may conveniently be provided by an electronic two-pole active filter providing the -12 DB attenuation below f.sub.1 and an analog differentiator for providing the -6 DB attenuation below f.sub.2. Above the f.sub.1 and f.sub.2 corner frequencies the active filter and analog differentiator respectively have substantially flat passbands. That portion of input signal 206a representative of the pulsatile blood pressure is differentiated and appears at the output of differentiating network 200 as signal 200a, hereinafter designated P.

This P signal (200a) is applied through amplifier 202 to the input of an integrator 204 which, by integrating the P signal over a predetermined interval during each pulse, provides an output value corresponding with the peak-to-peak pressure of each blood pressure pulse. Sample-and-hold circuitry 205 associated with integrator 204 serves to sample the value appearing at the output of integrator 204 at the end of each interval of integration and to hold that value for an interim period until integration of the next pressure pulse begins. Control of integrator 204 and sample-and-hold circuit 205 is provided by the RESET/INTEGRATE/HOLD-signal 208 which controls the period of integration and serves to clear the integrator prior to each new integration. The output from sample-and-hold circuit 205 appears on line 210 as waveform 210a having a magnitude which corresponds with the area under that portion of the waveform P being integrated.

Referring to FIGS. 3A and 3D for an understanding of the theory underlying the invention, it will be recalled from the aforementioned U.S. patent application Ser. No. 578,047 that the systolic pressure is equal to applied cuff pressure when the fluctuating quantity is about equal to one half the maximum of value of the fluctuating quantity. The maximum value of the fluctuating quantity is determined by measuring the diastole and systole in successive blood pressure pulses. That pulse exhibiting a maximum P-P amplitude is taken as the maximum value and the applied cuff pressure is further increased such that the P-P amplitude decreases and the systolic pressure is determined by noting the applied cuff pressure at which the P-P pressure becomes one half of the P-P maximum.

FIG. 3A illustrates the time-dependent fluctuating component, P.sub.ac, representative of pulsatile pressure within a blood vessel. The root ED of each valley in the P.sub.ac waveform corresponds with the time of diastole, or more specifically end diastole in a heart beat and the waveform peak SP corresponds with the time of systole in the heart beat. As earlier described, the signal from the cuff is differentiated to remove the applied pressure ramp and low frequency random perturbations, and results in the derivative P of waveform P.sub.ac, as represented in FIG. 3B. Because waveform P.sub.ac exhibits zero slope at both end diastole (ED) and the systolic peak (SP), the derivative waveform P will be of zero magnitude at each of those times. Further, because P.sub.ac exhibits a positive slope during the systolic rise between ED and SP, the P waveform lies above the zero reference line during this interval. The zero-crossing points ED and SP of the P waveform correspond with the points of maximum amplitude between successive P.sub.ac pulses and thus the area under the P waveform and above the zero reference between end diastole ED and the systolic peak SP provides a value which corresponds with the P-P value of the respective blood pressure pulse. This area is determined by integrating the "above zero" section of the P waveform. It should be noted that end diastole (ED) also corresponds essentially with the initiation of the rise to systolic peak (SP).

FIG. 3C illustrates a control signal generally similar to that of signal 208 in FIG. 2 which clears or resets the integrator prior to the interval of integration, then integrates the P signal over the interval of integration, and finally samples and holds the value of the integration as a representation of the P-P value of the respective blood pressure pulse. This sequence of control events is repeated with the resetting operation being indicated by R, the integrating operation being represented by .intg., and the sample and hold operation being represented by S+H. In fact, the sampled integral may be held longer than is suggested by the brief duration of the S+H signal in FIG. 3C.

The results of integrating the P waveform between the limits of ED and SP are illustrated in FIG. 3D. The magnitude of the integral at the time of the systolic peak SP corresponds with the P-P value of the respective blood pressure pulse.

In implementing the concept of integrating the P waveform over the interval of systolic rise to obtain respective P-P values for the respective blood pressure pulses or heart beats, standard circuitry may be used to detect when the P waveform crosses the zero reference in the positive going direction to begin the integration and to determine when it crosses the zero reference in the negative going direction to terminate the integration and/or perform the sample and hold function. The integrator may be reset immediately after sample and hold and preferably continue until the next positive going zero-crossing of P. The resulting integral may then be considered as representing the P-P value of the respective pulse. However, certain characteristics of the P.sub.ac waveform and/or the presence of signal artifacts during the diastolic drop may result in P appearing above the zero reference for a brief time other than between end diastole and the systolic peak. For instance, as illustrated in FIGS. 3A and 3B, if random muscular activity introduces a "high frequency" signal artifact (ART) just prior to end diastole when the slope of the P.sub.ac waveform is relatively flat, the derivative P waveform may present part of the artifact as a "greater than zero" value and result in the tentative values illustrated parenthetically in FIGS. 3C and 3D.

In accordance with an aspect of the invention, illustrated generally in FIG. 9, a threshold level is established for discriminating between those P values greater than zero which attend the systolic rise and those signals, such as artifacts and the like, which do not attend the systolic rise. The magnitude of P signal associated with the systolic rise is normally significantly greater than the magnitude of any other (above zero) portion of the signal (as from artifacts) and accordingly, this allows discrimination between such signals. The determination that the P waveform exceeds the threshold level during a particular "above zero" passage serves to validate the integration of that "above zero" passage between its respective ED and SP limits.

Referring to FIG. 9, in which those components functionally identical to corresponding components in FIG. 2 are identically numbered, the input signal 206a is differentiated by differentiating network 200 to provide the P waveform which is passed through amplifier 200 to the respective inputs of integrator 204, a threshold detector 912, and a zero-crossing detector 907. The zero-crossing detector 907 may correspond with means, not shown in FIG. 2, which established the interval of integration and resulted in the control signal 208 therein. The threshold detector 912 establishes a signal magnitude threshold value above which the P waveform is presumed to be indicative of a valid systolic rise. When the incoming P waveform exceeds the threshold level of detector 912, a signal is provided to the input of validating logic 914 indicative of such threshold level having been exceeded. Similarly, the validating logic 914 receives an input from the output of the zero-crossing detector 907 to define when the P waveform crosses a zero reference in the positive going direction and also in the negative going direction. The output 908" from validating logic 914 is applied to the RESET input of integrator 204 for resetting the integrator at least substantially at the beginning of each desired period of integration beginning with the P waveform crossing the zero reference in the positive going direction. The output 908 from validating logic 914 is applied to the "sample" input of the optional sample -and-hold circuit 205 and serves to store the integral value accumulated by integrator 204 between the positive going and negative going zero crossings of the P waveform only if threshold detector 912 has provided an indication that the P waveform during that interval was in fact a valid systolic rise. The output 910 of sample-and-hold circuit 205 varies from the output of 210 of FIG. 2 only where the latter might have included an invalid output value representative of a systolic rise when in fact only an artifact was present.

While a threshold of fixed magnitude above the zero reference might be utilized if an "above zero" portion of the P waveform did not vary in magnitude in successive pulses, such is not the case, particularly when using the present oscillometric blood pressure monitoring techniques in which the ac pressure signal P.sub.ac increases from a small amplitude at a low applied pressure to a large amplitude at a larger applied pressure and then to a smaller amplitude at a still larger applied pressure. Therefore, the threshold level, indicated as TRLD in FIG. 3B, is selected to be a function of the magnitude of the systolic rise portion of the P signal over one or more of the immediately preceding blood pressure pulsations. The increase (and subsequently decrease) in magnitude of successive systolic rises in the P waveform is sufficiently gradual, and the relative amplitude of any "above zero" non-systolic rise components of the P waveform are sufficiently small, that a dynamic threshold which corresponds with 50% of the maximum "above zero" amplitude of the systolic rise of the P waveform during the preceding pulse is herein considered sufficient for recognizing only those "above zero" portions of the P waveform which, in fact, attend the systolic rise.

It will be appreciated that the dynamic threshold level might be established by summing and weighting several prior systolic rise portions of the P waveform in which case threshold TRLD might be at a preselected level greater or less than 50% of the magnitude of the immediately preceding systolic rise. *An analog example of a dynamic threshold detector of the type suitable for application herein is described in greater detail in U.S. Pat. No. 3,590,811 to Harris for Electrocardiographic R-wave Detector. Digital means for establishing a dynamic threshold level will be described hereinafter in greater detail.

Reference is now made to FIGS. 4,6, and 7 for a more detailed description of the apparatus and process of one aspect and embodiment of the invention. The apparatus is described with reference to the functional block diagram of FIG. 4 which provides for the digital processing of the analog signal received from transducer 23. However, it will be appreciated that analog implementation is similarly possible. More specifically, discrete electronic components, discrete digital chips, microprocessor technology and structure, or digital computer can be employed. FIGS. 6 and 7, respectively, comprise a state diagram and a flow chart, or decision tree, associated with the processing of the P signal between successive blood pressure pulses corresponding with successive beats of the heart. Generally speaking, the signal processing steps of the improved blood pressure monitoring apparatus and technique of the invention, illustrated in FIGS. 6 and 7, correspond with that portion of the FIG. 4 apparatus which integrates the P signal between the limits ED.fwdarw.SP.

The arm 11 of a test subject with artery 13 therein is surrounded by a typical blood pressure cuff 15. Typically, the brachial artery located in the upper arm is employed for this type of blood pressure measurement. Attached to the cuff via conduits 17 and 21 are pump 19 and pressure transducer 23, respectively. Transducer 23 has a transfer function such that its electrical output is substantially representative of its pressure input up to the limit of information contained in the pulse pressure. The pressure transduce