AU615263B2 - Automated means arterial blood pressure monitor with data enhancement - Google Patents

Description

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COMMONWEALTH OF AUSTRALIA PATENTS ACT 1952 Form COMPLETE SPECIFICATIO 1 2 6 3

(ORIGINAL)

FOR OFFICE USE Short Title: Int. Cl: 4 0W4 0 4 9 0 04 40 Application Number: Lodged: Complete Specification-Lodged: Accepted: Lapsed: Published: Priority: Related Art: TO BE COMPLETED BY APPLICANT 4 Name of Applicant: Address of Applicant: Actual Inventor: Address for Service: CRITIKON, INC.

4110 George Road, Tampa, FLORIDA 33614,

U.S.A.

MAYNARD RAMSEY, III; RICHARD MEDERO and RUSH W. HOOD, JR.

GRIFFITH HACK CO.

71 YORK STREET SYDNEY NSW 2000

AUSTRALIA

Complete Specification for the invention entitled: "AUTOMATED MEANS ARTERIAL BLOOD PRESSURE MONITOR WITH DATA ENHANCEMENT" The following statement is a full description of this invention, including the best method of performing it known to us:- 7929A/bm 7929A/bm

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Field of the Invention 4 o o o o 0 0 0 0 o o o 00 oo a 4a 00 04 00 This invention relates to automated blood pressure measuring apparatus and, more particularly, to stored program controlled monitors employing the oscillometric method of detection characterized by data purification and enhanced systolic, diastolic and mean blood pressure determination.

Background of the Invention 15 Automated blood pressure monitoring has rapidly become an accepted and, in many cases, essential aspect of human and veterinary treatment. Such monitors are now a conventional part of the patient environment in emergency rooms, intensive and critical care units, and in the operating theatre.

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7929A/bm 4 The so-called oscillometric method of measuring blood pressure is one of the most popular methods in commercially available systems. This method relies on measuring changes in arterial counterpressure, such as imposed by an inflatable cuff, which is controllably relaxed or inflated. In some cases the cuff pressure change is continuous, and in others it is incremental. In substantially all, a transducer monitors arterial counterpressure oscillations, and processing apparatus converts select parameters of these oscillations into blood pressure data.

°4 Of particular interest with respect to the principles of o.o the present invention are the concepts set forth in U.S.

q9 15 Patents.4,360,029 and 4,394,034 to M. Ramsey, III, which are commonly assigned with the instant invention. The Ramsey patents derive from common parentage, the former including apparatus claims and the latter including method claims, their division having been made in response to a restriction requirement during the prosecution. Both patents, however, carry common disclosures of apparatus and methods for artifact rejection in oscillometric systems, which have been in practice in the commercially a0.0 successful DINAMAP brand monitors, which are manufactured and marketed by Critikon, Inc., of Tampa, Florida, the assignee hereof. In accordance with the Ramsey patents, an inflatable cuff is suitably located on the limb of a patient, and is pumped up to a predetermined pressure.

Thereupon, the cuff pressure is reduced in predetermined fixed decrements, at each level of which pressure fluctuations are monitored. These typically consist of a DC voltage with a small superimposed variational component caused by arterial blood pressure pulsations (referred to herein as "oscillatory complexes"). Therefore, after suitable filtering to reject the DC component and to CRIK-67 rt ict a 12' .4 provide amplification, pulse peak amplitudes above a given threshold are measured and stored. As the decrementing continues, the peak amplitudes will normally increase from a lower amount to a relative maximum, and thereafter will decrease. The lowest cuff pressure at which the oscillations have a maximum peak value is representative of mean arterial pressure. The cuff pressures obtaining when stored oscillatory complex pulse peak amplitudes bear predetermined fractional relationships with the largest stored peak corresponding to the subject's systolic and diastolic pressures.

The Ramsey patents devote considerable effort and disclosure to the rejection of artifact data to derive accurate blood pressure data. Indeed, as is apparent from Fig. 2 of the Ramsey patents, the most substantial portion of the mearsurement cycle (denominated 11T311) is devoted to the execution of complex detection at the various pressure levels, measurement of signal peaks of true complexes, and processing those peaks in accordance with artifact rejection algorithms. Notwithstanding such efforts, the signal peak data collected sometimes incorporates data errors, ie, a data pattern inconsistent with the above described typical physiological response pattern of a subject as the artery 25 occluding cuff pressure monotonically decreases.

ft 009606 ft 6 6 60 6 0 9 06 o 0 0 0600 o 0 o 06 00 60 O 0 0 ft 6 0 0004 6 09 60 0 0069 o 6 0 *0 I Further, in a contemporaneous invention (Australian patent application no. 59810/86 for "OSCILLOMETRIC BLOOD PRESSURE MONITOR EMPLOYING NON-UNIFORM PRESSURE DECREMENTING STEPS", 30 the disclosure of which is incorporated herein by reference) oscillo-metric blood pressure measurements are effected with non-uniform, cuff pressure-dependent pressure decrements between successive oscillatory complex peak measuring intervals. Such a method of effecting oscillometric blood pressure measurements is facilitated by systolic, diastolic and mean blood pressure determining algorithms not heretofore employed.

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.'jj It is an aim of the present invention to provide improved oscillometric blood pressure determining apparatus and methodology. More specifically, an aim of the present invention is to purify the oscillatory complex peak amplitude data ensemble employed for blood pressure determination.

An advantage of a preferred embodiment of the present invention is that it has the provision of improved algorithms, methodology and apparatus for determining systolic, diastolic and mean arterial blood pressure.

Summary of the Invention In a first aspect, the present invention provides in combination in digital processor controlled automated blood pressure measuring apparatus operative in conjunction with a stored program: an inflatable cuff; means for inflating and deflating said cuff; pressure transducer means coupled to said cuff r4*(,f r for signalling the pressure existing in said cuff; S(d) means responsive to the pressure signalled by said transducer for generating a signal representing blood 25 pressure oscillation complexes sensed by said cuff and said Aa4 trr transducer coupled thereto; t 6 complex peak storing means for storing values characterizing the peak amplitudes of said sensed oscillation complexes at different cuff pressures; S.4 30 cuff pressure storing means for storing the ,as cuff pressures existing when said complex peak amplitudes arose; and mean arterial pressure determining means, said mean arterial pressure determining means comprising means for locating the maximum complex peak V amplitude stored in said complex peak storing means; 6526 S/KLS -3a- ip k 1! (ii) means for locating a successor complex peak amplitude value stored in said complex peak storing means, said successor being the one next occurring after said maximum complex peak amplitude arose; (iii) means, responsive to the value of said successor complex peak for selecting plural ones of the complex peak amplitudes which were generated at cuff pressures higher than that existing when said maximum complex peak arose; and (iv) determining means for determining mean arterial pressure from 1. said selected plural ones of the complex peak amplitudes, 2. the cuff pressures stored in said cuff pressure storing means corresponding to said selected plural ones, and 3. the cuff pressure which corresponds to said successor complex peak amplitude.

In a further aspect, the present invention provides in an automated oscillometric blood pressure monitor employing a pressurized cuff, means for controllably changing pressure to distinct cuff pressure levels in predetermined cuff pressure decrements, and means for 4" measuring arterial pressure oscillation complexes through '0o 25 cuff pressure measurement, a method for measuring mean coo arterial pressure comprising the steps of: O at each said level, detecting oscillation complexes, measuring and storing the peak thereof, and storing the identification of each associated prevailing cuff pressure level; finding the amplitude of the largest of said oor peaks, and recording the prevailing cuff pressure level stored in association therewith; S 4t identifying a cuff pressure level having a peak next following and smaller than said largest of said peaks; identifying, in response to the amplitude of said peak next following, plural peaks which occured at cuff 6 926S/KLS 4- "4 pressure levels larger than the cuff pressure level of said largest of said peaks; interpolating the amplitude of said identified plural peaks; and developing mean arterial pressure as a predetermined weighted average of the cuff pressure corresponding to said interpolated amplitude and the cuff pressures corresponding to at least one of said largest and said next following peaks.

A blood pressure cuff is applied about a subject's artery, and inflated above the systolic level thus fully occluding the artery for a full heart cycle. The cuff pressure is thereafter reduced to permit an increasing flow through the progressively less occluded artery, and a measure of the peak amplitudes of the successively encountered oscillatory complexes stored in memory. Also retained is the cuff pressure obtaining for each stored complex peak.

In accordance with a preferred embodiment of the present invention, the stored complex peak-representing data set is corrected for aberrations; and improved data *00000 processing operates on the stored (and advantageously corrected) pulse peak data and the corresponding cuff 0o ~pressure i0o0 t ilcr t 1111 1110 401 I I iMZ 6926S/KLS 4a information to determine the subject's systolic, diastolic and- mean arterial pressure.

Description of the Drawings The above and other objects and features of the present invention will be realized from the following detailed discussion of a specific, illustrative embodiment thereof, presented hereinbelow in conjunction with the accompanying 0:000:drawing, in which: Fig. 1 is a timing diagram illustrating data generation a and correction during an illustrative measurement cycle for oscillometric blood pressure determination in 0 0 accordance with the principles of the present invention; a Fig. 2 is a flow chart illustrating data purification for 0 improved oscillometric blood pressure determination; 0 0 Fig. 3 depicts oscillation amplitude processing for a systolic blood pressure measurement in accordance with the present invention; O 0 Fig. 4 is a program flow chart for the systolic blood pressure measurement typified in Fig. 3; Fig. 5 illustrates blood pressure interpolation for the processing mode of Figs. 3 and 4 (and by analogy for Figs.

6-9 as well); Fig. 6 depicts oscillatory complex measuring wave forms illustrating diastolic blood pressure determination in accordance with the present invention; CRIK-67 4: -E II~-YXUZ IIIY- I 6 Fig. 7 is a program flow chart illustrating the diastolic blood pressure measurement typified by Fig. 6; Fig. 8 is a timing diagram depicting oscillatory complex peak amplitude processing for mean arterial pressure measurements in accordance with the present invention; and Fig. 9 is a program flow chart illustrating the mean arterial pressure determination typified by Fig. 8.

Best Mode For Carrying Out the Invention So°° U.S Patent Nos. 4,360,029 and 4,349,034, each to Maynard 0 Ramsey, III, and Maynard Ramsey, III et al U.S. Patent No.

oo 15 4,543,962 for "IMPROVED METHOD OF AUTOMATED BLOOD PRESSURE 0 00 oo000 DETECTION" issued October 1, 1985 are incorporated herein by 0000 oot 0 reference, as is Australian Patent Application No.

0 59810/86. These patents and this patent applicationdescribe in detail the basic oscillometric method of measuring blood pressure forming a background and a starting point for the instant invention.

o00000 ao 0 o To review only briefly, an artery-occluding cuff is disposed on the subject, about a subject's upper arm over the 25 brachial artery. At the inception of a measuring cycle, the cuff is inflated to a pressure which fully occludes the brachial artery, prevents blood from flowing therethrough at any point in the heart cycle. The cuff is then progressively deflated, as in descrete steps. A pressure transducer is coupled to the internal cuff pressure and provides an analog signal characterizing the blood pressure oscillatory complexes when they begin to occur when the maximum heart pressure corresponding to contraction of the heart's left ventricle 1 6926S/KLS/07.06.91

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i- 1 -7exceeds the instantaneously obtaining artery-occluding cuff pressure). The peak values of the complex signals are determined in hardware or software.

As the measurement cycle progresses, the peak amplitude of the blood pressure complexes generally become monotonically larger to a maximum and then become monotonically smaller as the cuff pressure continues toward deflation. The peak amplitude of the cuff pressure oscillation complexes, and the corresponding Sq" occluding-cuff pressure values are retained in computer oO memory. The aforementioned Ramsey patents and patent 0 application illustrate previously employed algorithms for Qo processing the stored blood pressure complex peak values and concomitant pressure values to yield the subject's S° mean arterial pressure. These patents and applications also furnish detailed procedures for measuring oscillatory 0 0, complex peaks; procedures for testing complexes and 0 rejecting bad data associated with measurement-impeding artifacts (such as motion) during a measuring cycle, and the like.

p p The oscillometric blood pressure measurements as typified by the aforementioned Ramsey disclosures are effected under stored program control, as via a microprocessor operative in conjunction with a program containing read only memory (ROM or PROM), and a variable content random access memory (RAM) which stores the cuff pressures, oscillatory complex peak amplitudes, and other processing operand variables. The microprocessor receives the cuff pressure readings generated by the pressure transducer, for example as processed by a peak detector, amplifier and analog-to-digital converter, and supplies all output control signals required, to open and close one or more cuff deflating valves.

-7- The oscillometric method above described and more fully discussed in the aforementioned Ramsey patents and application may be conducted with several variations.

Thus, for example, the cuff may be inflated directly by an air pump; and deflated in fixed, discrete steps under microprocessor control. Alternatively, the cuff may be principally or entirely inflated by the pressurized contents of an air reservoir; and/or deflation may proceed in variable, cuff pressure-dependent steps via selected one or ones of plural deflating valves. These latter 0 11 alternatives achieve the desideratum of condensing the 0 00 time required for a composite measurement cycle of O 00 00 oo operation.

0000 o, 0 a 600Also. there are alternative procedures for measuring the 00 00 00 o0 oscillatory complex peak amplitude at any prevailing cuff pressure. In one mode heretofore employed, plural two) complex peaks are measured at each cuff pressure step during cuff deflation, and their average used as the peak value. Since the peaks should be approximately equal, any 00 marked disparity 20%) signals that some 0artifact error occurred and the data is rejected. In a 0000 fast ("stat") mode, after several intervals of qualifying 2S (close or equal peak values) companion complexes are :00detected to develop measurement confidence, only one pulse a 000 is required during succeeding cuff deflation intervals thus speeding the composite measurement period. Please see in this later regard US 4,543,962.

As alluded to above, it is sometimes the case when blood pressure complexes ate being examined for peak amplitude at any occluding pressure level that improper data is developed. There are varying causes for such 6 7 -9- 0 o Q 0 ~44 00 0 0 04 0 00 o o 0 o oo 0~4 00 O 0 0004 00 00 0 0 0 *004 4 04 00 4 44 4 0 0 O 44 14 04 0 4 0 4 4 OjOt 4 I aberrations. Perhaps the most common is spurious motion by the subject which generates an inadvertent pressure impulse in the cuff which is sensed by the pressure transducer which may be then incorrectly reflected in the blood pressure measurement. Other causes include varying sources of interfering electrical noise or internal cardiac or respiratory changes in the subject. When a false complex peak amplitude value is generated, it is discarded by the composite measuring apparatus and a 10 discard-signalling value retained in its place in memory.

A second form of spurious data occurs when the pattern of stored pulse peak values departs from the physiologically 15 mandated sequence of values which progressively increase to a peak and then progressively decrease.

Attention will now be directed to data processing under stored program control for purifying the data collected by the above-described blood pressure measuring apparatus.

Further, specific illustrative efficient algorithms are discussed for in fact determining the subject's systolic, diastolic and mean arterial blood pressures. Such data processing may be effected on any computing equipment, preferably digital microprocessors such as commercially available from a number of vendors. The program instructions and sequences presented below are for illustrative purposes only. Such instructions may in fact be implemented in any of diverse program languages and sequences readily apparent to those skilled in the art.

In the signal processing below discussed, processing variables have the following significance: 4..

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CRIK-67 1 -a~^.-rwcurrraaarrrrr~ I. Variables Employed For All Data Processing Below Discussed Variable Functional Quantity Represented CP(I) The cuff pressure, measured by the transducer pneumatically coupled to the artery occluding cuff, obtaining during the i-th deflation step.

o CP(I) is an indexed array, i.e., s0 there exists a plurality of values for CP(I) characterizing 0i each of the i deflation steps.

0 0Q 0 IA(I) The peak amplitude of the oscillometric oscillation the complex peak amplitude) occur- S, ring at the i-th step. Where S 20 multiple complexes are measured during each prevailing deflation pressure, QA(I) is the average of two (or more) peak amplitudes during the i-th step. DA(I) is an indexed array.

OA(MAX) The peak value of the array of averaged oscillatory blood Spressure complex amplitudes.

MAX The time interval when the peak complex A(MAX) occurred. CRIK-67

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4-I -11- II. Variables Specific To Systolic Pressure Measurement Variable

LVL

Functional Quantity Represented An intermediate processing variable representing a predetermined fraction of QA(MAX).

The subject's measured systolic pressure.

Variables Functional Quantity Represented V t 4 4* 40 o 00 O 4 *040 to I 4 4 4i I I 4

SYS

III. Diastolic Pressure Variable UDLVL and LDLVL Intermediate processing variables each representing a different fraction of QA(MAX).

DIAU, DIAL Intermediate processing variables representing upper and lower interpolated diastolic pressure computational variables.

DIA The subject's measured diastolic pressure.

IV. Mean Arterial Pressure Processina Variables t 4oa49 4 4 Variable

AMP

Functional Quantity Represented The complex pulse peak for the deflation interval following that 1

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The following statement is a full description of this invention, including the best method of performing it known to us:- 7929A/bm i I 1% -12 i for which the pressure oscillation amplitude was the maximum.

MAPL An intermediate processing variable employed in the final mean arterial pressure computation.

MAP The subject's mean arterial blood pressure.

oTurning now to Fig. 1, there is depicted wave forms with a oooassociated data characterizing the generation of data for O -an oscillatory blood pressure measurement and purging ,(overcoming) bad data constituents. In accordance with o, 15 the above discussion, the cuff artery occluding pressure for a measurement cycle, as measured by the cuff-associated transducer, is characterized by a wave Sform 10. The cuff pressure rapidly increases to a maximum 1 above the subject's systolic pressure, and is then deflated in a sequence of steps to a point below the diastolic pressure. The sequence of cuff deflation steps is indicated by the time interval signalling digits 1,2, (lowest row 18 in the data table portion of Fig.

The internal pressure characterizing the cuff pressure at each step i is given by the data array CP(l),CP(2). (upper data table row 12).

Each step (time interval) is made sufficiently long to include at least two heart beats. Accordingly, at least two cuff pressure complex pulses 21. and 22 are measured during each interval after such pulses begin.

Legends have been applied to pulses occurring during deflation steps 6 and 9 to avoid clutter and loss of i clarity in Fig. 1. No pulses are measured during the p first and second pressure steps (time intervals), it being -13 assumed that the cuff pressure [CP(1)=201 Torr., and CP(2)=194 Torr.] are sufficient during these periods to obviate blood flow through the subject's artery for the full heart cycle. During the following intervals 3,4 two oscillometric complex pulses 21 and 22 are generated and measured, the two pulses having an average peak amplitude 23 (the processor variable array value initially stored in The measured oscillation amplitude array is shown in the second row 14 of the Fig. 1 data table for each time interval.

0 0 As above noted, assuming a perfect measurement, the Soscillation pressure amplitude OA(I) data row would not '4 4contain any +1 values which signify an impeded A DO 15 measurement. Further, the data pattern in the second row of the data table for the oscillation amplitudes would exhibit a pattern of successively increasing numbers to a S'peak value, followed by progressively decreasing values all without adjacent equal QA(I) values. To the extent that any 4A(I)=1 values are stored, or to the extent that the progressively increasing/decreasing pattern does not obtain, the data processing in accordance with the instant invention functions to compute appropriate corrected QA(I) values (the third data table row 15 in Fig. 1) for the oscillation amplitude entries requiring correction.

In overview, where any 4A(I)=1 values exist, they are replaced by the average value of the oscillation amplitude in the two contiguous storage cells, i.e., (QA(I-1) Eq. 1.

Correspondingly, where two contiguous oscillation amplitudes have the proscribed equal values, the first of CRIK-67 1 ll g 1 CRIK-67.

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-14the contiguous equal pair is replaced by the average of the amplitudes of the complex peaks measured at the next lower and next higher occluding cuff pressures. See, for example, Eq. 1 and, more particularly, the comparable relationship in functional block 30 of Fig. 2.

Data flow effecting the data purification algorithm above-discussed is set forth in the program flow chart of Fig. 2. Fig. 2 operates on the measured average oscillation amplitudes (the second data table row 14 in Fig. 1) and generates the corrected values shown o in the third row 15 of Fig. 1. To this end, proceeding from a start block 10 (Fig. step 15 reads the next e" value (proceeding toward the right along the Fig.

o 15 1 data table row 14) and test 18 determines whether the a0 C a' the like), control passes to equality test 27. However, if the contents of OA(I) did equal +1 ("YES" branch of So a test 18), functional block 23 implements Eq. 1i, i.e., replaces the +1 former contents of memory cell 1A(I) corresponding to cuff pressure CP(I) with the average a; value of the oscillation amplitude measured at the next lower and next higher non-plus one (QA(I+1)) deflation steps. The processing steps 18 and 23 thus purge the measured pressure peak amplitude storage contents (the second row of the Fig. 1 data table) of all +1 values, replacing these by the average value of the measurements made during immediately adjacent deflation steps (corrected tA(I) contents being illustrated in row Test 27 next examines the current operand wA(I) for the CRIK-67 v s in A f asis he uual aseit des nt (ndictingtha "['stevlu esrdwa rsmtveyfe fariat n 6 9-26S/KLS -3 I

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proscribed equality with :-the previous value (DA(I-1).

If. as is normally the case, the contents of OA(I) and (DA(I-1) differ branch from test 27). processing flows to test 32 to determine whether each of the N elements of 0DA(I) have been processed. If they have not. control returns to block 15 to read in and process the next 4DA(I) element of the array in the third row of the Fig. 1 data table. When all elements have been processed, control exits from the Fig. 2 data purification routine to data processing point 33 to proceed with the next (unrelated) task for the microprocessor.

If a data error has occurred ("YES" output of test 27 signalling that a data value (DA(I) equaled the previous 15 value), control passes to step 30 which replaces the assumed erroneous element cA(I-1) (the value which should differ from OA(I) but did not) with the average of the two immediately contiguous elements, as by 01. o6 It a 0 00 0 0 0 0 0 0 0 GO 00 0000 44 0 I)+4A( 1-2) Eq. 2.

4 Accordingly, the data purification routine depicted in Fig. 2 and above-discussed replaces all error reading 4004~ 25 signifying 0A(I>=1 values with an interpolated estimated value; and purges the data table row 14 (DA(I) array of data of any contiguous equal values. The corrected set of (DA(I) is shown in the third row 15 of the Fig. 1 data table. Thus, for example, the oscillation amplitude value during the cuff pressure step (time interval) "14" is corrected from the error-signalling +1 value to a peak amplitude 14, representing the average of measurements 4 and 25 at cuff pressures 187 Torr. and 153 Torr.during the immediately contiguous time intervals 3 and 5. Similarly, the first (pressure step 6) of two equal measured oscillation amplitude pulses of value 63 during periods 6 CRIK- 67 i

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-16and 7. corresponding to occluding cuff pressures of 140 Torr. and 128 Torr., is corrected to a value of 44 representing the average of the contiguous measured amplitudes of 63 and 25 units.

The corrected array DA(I) as represented by the third row 15 in Fig. 1 thus comprises value from which each of the systolic, diastolic and mean arterial blood pressures may be determined either in accordance with the improved algorithms below discussed or employing the algorithms of the above referenced patents and patent application The 0o 0 data purification above discussed provides more accurate 0Q, measurements than was heretofore the case; and also permits blood pressures to be determined more quickly, oo 15 obviating the need for repeated deflation steps when unacceptable artifact or noise corrupted data is sensed.

sit#Attention will now be shifted to the particular method Spursuant to which the stored cuff pressure CP(I) and 0 20 corrected blood pressure peak value sA(I) information in Sthe first and third data rows of Fig. 1 is employed in Saccordance with other aspects of the present invention to measure a subject's systolic, diastolic and mean arterial blood pressures.

S Pulse complex wave form processing typifying systolic blood pressure determination is illustrated in Fig. 3. and a flow chart for the underlying data processing is set forth in Fig. 4. In overview, systolic pressure is determined by: Finding the amplitude (A(MAX)) of the largest blood pressure oscillatory complex (which occurs at the time interval MAX); i *e i 0 1 5 b i t e f e e e i e o 9 ~i k: .°uacpal rifc rniecrupe aai esd If -17- Finding an amplitude level (LVL) equal to a predeterminted fraction of the peak value QA(MAX). We have found a value of 0.5 to be satisfactory for normal processing with something less 0.45) for stat (rapid deflation and/or single pulse) operation; Examining the corrected oscillation amplitude values (third row 15 in the Fig. 1 data table) starting at the MAX interval and proceeding toward the higher cuff pressure direction to the left in Figs.

1 and 3) to find the two contiguous oscillation amplitudes for which S A(L) MAX*0.5 Eq. 3.

Soscillation amplitude and cuff pressure between the Sintervals L and L+1. This per se well known linear trapezoidal interpolation is graphically depicted in Fig.

The interpolated cuff pressure directly corresponds to the subject's systolic blood pressure (SYS).

Expanding upon the systolic pressure determining methodology set forth above, the cuff pressure interval I=MAX when the largest oscillation amplitude peak occurs is determined in any per se well known manner, (step 40 of the Fig. 4 flow chart corresponding to the interval MAX in Fig. 3).

Thus, for example, the following schematic BASIC sequence will suffice as illustrative to find the interval MAX: QAMAX=4A(L1) Eq. 4.

MAX=1 Eq. F)R K=2 TO N Eq. 6.

CRIK-67 he ubje t's sys olic blo d p essu e YS) -18- IF OA(K) OAMAX GOTO 70 Eq. 7.

OAMAX=OA(K) Eq. 8.

MAX=K Eq. 9.

NEXT K Eq. In brief, Equations 4 and 5 make an initial assumption that the peak value occurred during the first interval and load a provisional peak value storing variable OAMAX with the value 0A(1). For an assumed N-time interval measurement, the loop between Equations 6 and sequentially examines every element of the QA(I) array o o from 2 to N, updating AMAX only when the value A(K) 0 0.

a (K being the loop index) exceeds the previously assumed °AMAX value. When the processing exits from the loop S 15 following instruction 70 in Equation 10 the variable MAX e contains the value of I such that OA(MAX) is the largest value in the array.

*i The next following step 42 sets a variable LVL equal to 20 the predetermined fraction of the peak amplitude OA(MAX) as by Eq. 11.

The value LVL is shown by the dashed line 50 in Fig. 3.

The next following operation 45 finds the first time interval preceding MAX for which the oscillation amplitude peak is less than LVL, less than one-half of the peak value 4A(MAX), thereby finding the two contiguous values L+l) having peak amplitudes which bound the value in LVL. Algorithms for conducting such a search are well known to those skilled in the art, e.g., FOR J=l TO MAX Eq. 12.

CRIK-67 I i:J il i r; _1 CRIK-67 -19- IF (DA(MAX-J)-LVL) 0 GOTO 140 NEXT J 140 L=MAX-J Eq. 13.

Eq. 14.

Eq. 0 0 0 0 00 <0 0 0 04D 0 0 o o 0 0 0 0*t 00 9 o 0 o0 0 0 0 0 4 Equations 12-15 simply comprise a DO or FDR-NEXT loop progressing from MAX-1 toward L=l. exiting when the first sub-LVL value is obtained. The appropriate interval identification (MAX-J) is stored in the variable location

L.

Finally, the value of the systolic pressure is estimated by assuming a linear variation in cuff pressure between the values CP(L) and CP(L+1), and a linear variation between the corresponding oscillation amplitude DA(L) 15 and DA(L+l). Thus, in accordance with the per se well known trapezoidal interpolation equation, the systolic pressure SYS may be determined (step 47 of Fig. 4) by SYS=CP(L) <DA(L+l)-OA(A) Eq. 16.

To illustrate employing the data of Fig. 1, 50% of the peak amplitude (70) is 35, and thus the pulse complex measurements of time intervals 5 and 6 are selected for systolic pressure computation. The Eq. 16 software interpolation implementation yields: SYS=153+((140-153)x(35-25)/(44-25)); =149 Torr.

Eq. 17.

Eq. 18.

assuming three significant figures.

Pulse complex wave form processing characterizing diastolic blood pressure determination is illustrated in Fig. 6; and a flow chart for the underlying diastolic data CRIK-67

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It 1 processing algorithm is depicted in Fig. 7. In overview, diastolic pressure is determined by: the amplitude of the complex (which occurs at the time interval MAX); Finding an amplitude level (UDLVL) equal to a first predetermined fraction of the peak value QA(MAX). We have found a value of 0.69 to be satisfactory for normal processing and 0.72 for rapid ("stat") processing; Examining the corrected oscillation amplitude o 440 buffer 15 (Fig. 1) starting at the MAX interval Oa 'and proceeding toward the lower cuff pressure direction O to the right in Figs. 1 and 6) to find the two So 15 contiguous oscillation amplitudes for which e 0 O 4 QA(UD) MAX*0.69 DA(UD-1); Eq. 19.

t t Finding the interpolated cuff pressure (between 20 CP(UD-1) and CP(UD)) assuming a linear variation in oscillation amplitude and cuff pressure between the intervals UD-1 and UD (processing variable DIAU in Fig. 7); Examining the stored OA(I) oscillation amplitude values at pressures starting at the lowest cuff pressure measured for a contiguous pair bounding the peak amplitude 0A(MAX) multiplied by a second factor lower than the first factor 0.55), where OA(LD) MAX*0.55 O(LD-1); Eq. Computing the interpolated cuff pressure between CP(LD) and CP(LD-1) corresponding to MAX times the 0.55 factor. This lower interpolated cuff pressure is associated with the variable designation DIAL: and CRIK-67 1 -21- Determining the subject's diastolic pressure (DIA) as the average of the upper and lower interpolated values DIAU and DIAL. i.e., DIA=(DIAU+DIAL)/2. Eq. 21.

The above-described procedure is illustrated in the blood pressure complex depiction of Fig. 6 and the Fig. 7 flow 10 chart. The peak 4DA(MAX) is first located as by the 0 processing of Equations 4-10. The upper and lower peak o amplitude fractions DIAU and DIAL are next determined (steps 64 and 65 of Fig. 7 corresponding to the labeled horizontal dash lines in Fig. Step 69 then finds the first time inerval (UD) following MAX at which the peak 0 amplitude DA(UD) is lower than the value stored in DIAU (as by processing analogous to that of Equations 12 through 15 replacing "MAX-J" with Thereafter, step 72 performs the trapezoidal interpolation analogous t 20 to that of Fig. 5. determining the cuff pressure (DIAU) corresponding to the UDLVL complex amplitude value. It is observed that the time interval UD-1 coincides with the interval MAX when the peak complex value occurred since, for the data case illustrated, the first pulse complex t 1 following MAX less than 0.69 x DA(MAX) occurred in the next time interval MAX+1.

The functional steps 73 and 74 of Fig. 7 perform in a manner directly analogous to operations 69 and 72, locating the cuff pressure DIAL by interpolation for the intervals when the peak complex amplitudes bound the LDLVL value equal 0A(MAX) times 0.55. This latter search is V conducted from OA(i) at the lowest cuff pressure, then working toward higher cuff pressures. Finally, the subject's diastolic pressure (DIA) is compute6 as the CRIK-67

VL

1 Y 'ul~n -22average of the contents stored in DIAU and DIAL (step 82).

To illustrate with a numerical example, again employing the data portion of Fig. 1, DIAU=83+((93-83)x(48-40))/(40-53)=71. Eq. 22.

DIAL=74+(83-74)x(38-33))/(33-40)=67. Eq. 23.

DIA=(71+67)/2 69. Eq. 24.

Finally, wave form processing illustrating mean arterial Oo blood pressure measurement is shown in Fig. 8, and in flow oo chart form for the corresponding data processing in Fig.

o 9. In summary, mean arterial pressure is determined by: 0> Finding the amplitude (OA(MAX)) of the largest blood complex (which occurs at the time interval MAX); Examining the cuff pressure values in the corrected 20 register 15 (Fig. 1) for the interval MN1 yielding the r, ao first oscillation amplitude less than OA(MAX+1), i.e., the first cuff pressure to the left of the interval MAX which was less than the complex peak amplitude QA(MAX+l) 4 occurring in the first interval following the time MAX.

This satisfies the relationship 4A(MN1) 4A(MAX+1l) (DA(MN1+1); Eq. An interpolation is then conducted between the intervals MN1 and MN1+1 for a cuff pressure MAPL corresponding to the oscillation amplitude value OA(MAX+1); and Finally, the mean arterial pressure (MAP) is determined by a weighting of the cuff pressures CP(MAX+1) CRIK-67 CRIK-67

I

-23and MAPL, as by MAP=(CP(MAX+1)+(2*MAPL))/2.9 Eq. 26.

The denominator (2.9 in Eq. 26) may be somewhat lower for operation in a "stat" mode, 2.85.

The above-discussed algorithm for determining mean arterial pressure is illustrated in Figs. 8 and 9. Step 101 (Fig. 9) finds the peak interval MAX (for example, by 4execution comparable to Equations 4-10). A processing variable AMP is set equal to the peak value QA(MAX+1) of the complex following the interval MAX (step 105) and the interval MNL is next determined (step 106) as the first occurring complex less than the value AMP operation 113 finds the subject's mean arterial pressure by implementing Equation 26.

To again illustrate by numerical example from the Fig. 1 data MAPL=140+((128-140)x(62-44))/(63-44) 129 Eq. 27.

MAP=(104+2*129)/2.9 124 Eq. 28.

The foregoing discussion has thus demonstrated that measured data may be enhanced by replacing data lost through measurement artifacts or the like or deviations from a proper data pattern by approximated values.

Specific data processing algorithms were presented and discussed for the computation of a subject's measured CRIK-67 CRIK-67l L' I I i! -24systolic, diastolic and mean arterial blood pressures.

The above-described arrangements are merely illustrative of the principles of the present invention. Numerous modifications and adaptations thereof will be readily apparent to those skilled in the art without departing from the spirit and scope of the present invention. For 4 example, the pressure measurement mode is described above as stepped deflation from an initial inflation above the 41 subject's systolic pressure. The measurement of the instant invention can alternatively be performed by oi stepped inflation from an initial sub-diastolic cuff ,r pressure; or via continuous vis-a-vis discrete cuff 15 inflation or deflation.

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S' CRIK-67 9..

Claims (7)

1. In combination in digital processor controlled automated blood pressure measuring apparatus operative in conjunction with a stored program: an inflatable cuff; means for inflating and deflating said cuff; pressure transducer means coupled to said cuff for signalling the pressure existing in said cuff; means responsive to the pressure signalled by said transducer for generating a signal representing blood pressure oscillation complexes sensed by said cuff and said transducer coupled thereto; complex peak storing means for storing values characterizing the peak amplitudes of said sensed oscillation complexes at different cuff pressures; cuff pressure storing means for storing the cuff pressures existing when said complex peak amplitudes arose; and mean arterial pressure determining means, said mean arterial pressure determining means comprising means for locating the maximum complex peak amplitude stored in said complex peak storing means; (ii) means for locating a successor complex peak 25 amplitude value stored in said complex peak storing means, said successor being the one next occurring after said maximum complex peak amplitude arose; (iii) means, responsive to the value of said successor complex peak for selecting plural ones of the complex peak 30 amplitudes which were generated at cuff pressures higher than that existing when said maximum complex peak arose; and (iv) determining means for determining mean arterial pressure from said selected plural ones of the complex peak 35 amplitudes, the cuff pressures stored in said cuff pressure storing means corresponding to said selected plural ones, and 0 0a 0 0 0 i0 00000, t* a 0 040 0 00

04.40 00 00 f t 00 0 4 0 0 9 0 0 o o 0 90 0 9 0 00 *0 00 0 9 0 0 0 0 0 0 0 00 0 0 0 00 0 00 0 040 «9 0 C 9000 a 4 a a 0 i 4 44 4 fi: f:~ isr r ia :li~. II a :Bi~ .6926S/KLS 114 '4. 'I 6926 25 i i n' mg7j !.7 i s 26 the cuff pressure which corresponds to said uccessor complex peak amplitude. 2. A combination as in claim i, wherein said determining means comprises means for interpolating plural of the complex peak amplitudes and the cuff pressures corresponding thereto. 3. A combination as in claim i, wherein said determining means comprises means for computing a weighted average of the cuff pressure stored in said cuff pressure storing means corresponding to said successor complex peak signal and a function of the cuff pressures stored in said cuff pressure storing means corresponding to said selected plural complex 15 peak value. 0 0 0 00 0) 00 0 0n 0000 001 *0 00 0 0 0 0 0 00-00 0 0 00 0 0 00 00 0 000 0.0 .0 0 4 4. A combination as in claim 1, and further including data purifying means, operative upon the complex peak amplitudes stored in said complex peak storing means, for correcting data inacuracies prior to operation of said mean arterial pressure determining means.

5. A combination as in claim 4, wherein a preselected character is stored in said complex peak storing means to 25 signal an unsuccessful pulse flow peak measurement, and wherein said data purifying means comprises means for examining the contents of said complex peak storing means and said means for examining being responsive to detecting said preselected character for replacing said character with a function of plural stored complex peak values at least one of which was obtained at a cuff pressure higher than that associated with the preselected character and at least one of which was obtained at a cuff pressure lower than that associated with the preselected character.

6. A combination as in claim 4, wherein a preselected character is stored in said complex peak storing means to signal an unsuccessful pulse flow peak measurement, and 6926S/KLS/07.06.91 -i 27 wherein said data purifying means comprises means for examining the contents of said complex peak storing means, the means for examining being responsive to detecting said preselected character for replacing said character with a measure of plural stored complex peak values at least one of said stored values having been obtained by the average of the cuff pressures next higher and next lower than that associated with the preselected character.

7. A combination as in claim 4, wherein said data purifying means includes means for searching said complex storing means for the occurrence of two equal peak amplitude values arising at successive cuff deflation pressures, and means responsive to said searching means for replacing one 15 of the two stored equal values with a function of two other values stored in said complex peak storing means.

8. A combination as in claim 4, wherein said data purifying means includes means for searching said complex storing means for the occurrence of two equal peak amplitude values arising at successive cuff deflation pressures, and means responsive to said searching means for replacing one S1 of the two stored equal values with the average of the next higher and the next lower values stored in said complex peak S 25 storing means.

9. In an automated oscillometric blood pressure monitor employing a pressurized cuff, means for controllably changing pressure to distinct cuff pressure levels in predetermined cuff pressure decrements, and means for measuring arterial pressure oscillation complexes through cuff pressure measurement, a method for measuring mean arterial pressure comprising the steps of: at each said level, detecting oscillation complexes, measuring and storing the peak thereof, and storing the identification of each associated prevailing cuff pressure level; 6926S/KLS/07.06.91 II finding the amplitude of the largest of said peaks, and recording the prevailing cuff pressure level stored in association therewith; identifying a cuff pressure level having a peak next following and smaller than said largest of said peaks; identifying, in response to the amplitude of said peak next following, plural peaks which occured at cuff pressure levels larger than the cuff pressure level of said largest of said peaks; interpolating the amplitude of said identified plural peaks; and developing mean arterial pressure as a predetermined weighted average of the cuff pressure corresponding to said interpolated amplitude and the cuff pressures corresponding to at least one of said largest and said next following peaks. A method as described in claim 9 and further including the steps, prior to said finding step, of comparing said 20 stored peaks with predetermined standards, and of 0o, substituting corrected peak data for those peaks which depart from said standards. a I *1 1 t 25 DATED this 7th day of September 1990 CRITIKON, INC. By their Patent Attorneys GRIFFITH HACK CO. 4 i! T' 6926S/KLS 28 rvLY I