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Method and apparatus for performing non-invasive blood pressure and pulse rate measurements    

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United States Patent4271844   
Link to this pagehttp://www.wikipatents.com/4271844.html
Inventor(s)Croslin; Michael E. (Forest Hills Gardens, NY)
AbstractThere is disclosed a blood pressure measuring instrument which utilizes a standard cuff, a bulb for manually pumping up the cuff pressure, and a bleed hole which allows the cuff pressure to decrease at the rate of a few mm Hg per second. A single pressure transducer is in communication with the cuff interior and its output is sampled at a rate much higher than that of the blood pressure pulses. The sampled data, representing the occluding pressure which is being pumped up or bleeding down, with blood pressure pulses superimposed on it, are used to monitor the pump-up procedure and to determine when the artery is completely occluded, to analyze each blood pressure pulse for validating it and for measuring its amplitude, to determine systolic pressure only if the pulse amplitude sequence is a valid sequence, to determine diastolic pressure by comparing decreasing average pulse amplitudes with a threshold level dependent upon maximum pulse amplitude data, and to determine pulse rate in accordance with the number of pulses detected during a fixed time interval. A display circuit guides the operator as to the steps he must take in accordance with the present system state, and it displays both error messages and measurement values. The high reliability of the system is a consequence of the particular methodology employed during each processing step; the high sampling rate allows the system to follow instantaneous pressure changes, and the various analytical routines take full advantage of this capability.
   














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Drawing from US Patent 4271844
Method and apparatus for performing non-invasive blood pressure and

     pulse rate measurements - US Patent 4271844 Drawing
Method and apparatus for performing non-invasive blood pressure and pulse rate measurements
Inventor     Croslin; Michael E. (Forest Hills Gardens, NY)
Owner/Assignee     Medtek Corporation (Princeton, NJ)
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Publication Date     June 9, 1981
Application Number     06/064,194
PAIR File History     Application Data   Transaction History
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Litigation
Filing Date     August 6, 1979
US Classification     600/494
Int'l Classification     A61B 005/02
Examiner     Kamm; William E.
Assistant Examiner    
Attorney/Law Firm     Gottlieb, Rackman & Reisman
Address
Parent Case     This application is a continuation-in-part of my application Ser. No. 000,499, filed Jan. 2, 1979 and entitled "Method and Apparatus for Non-Invasive Detection of Arterial Blood Pressure and Pulse Rate, and Monitoring the Results of Analysis Apparatus", and a continuation-in-part of my application Ser. No. 774,970, filed Mar. 7, 1977 and entitled "Method and Apparatus for Non-Invasive Detecting of Arterial Blood Pressure and Pulse Rate, and the Monitoring of Detected Results" (the former being a continuation-in-part of the latter), both of which applications are hereby incorporated by reference.
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USPTO Field of Search     128/680 128/681 128/682 128/683 128/677
Patent Tags     performing non-invasive blood pressure and pulse rate measurements
   
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I claim:

1. A method for determining systolic pressure as the occluding pressure existing in the cuff of a blood pressure measuring instrument bleeds down; said instrument including means for allowing air in said cuff to bleed out, and means for periodically sampling the instantaneous cuff pressure; comprising the steps of:

(a) utilizing successive samples taken for detecting the presence of a predetermined number of successive blood pressure pulses and the amplitude of each,

(b) registering the occluding pressure in said cuff at the onset of each blood pressure pulse,

(c) comparing the detected sequence of the relative amplitudes of said predetermined number of blood pressure pulses with a plurality of known valid sequences to determine if the detected sequence is valid, and

(d) if the detected sequence is valid, determining the systolic pressure to be the registered occluding pressure at the onset of a predetermined one of said blood pressure pulses.

2. A method in accordance with claim 1 wherein said predetermined number is four.

3. A method in accordance with claim 1 wherein said predetermined blood pressure pulse is the third in the sequence.

4. A method in accordance with claim 1 wherein step (a) includes the sub-steps of:

(a1) maintaining an occluding cuff pressure value and continuously up-dating it in accordance with a newly taken sample if the latter is smaller,

(a2) determining the onset of a blood pressure pulse when a newly taken sample exceeds said occluding cuff pressure value,

(a3) maintaining a maximum pressure rise value after the onset of a blood pressure pulse, and continuously up-dating it in accordance with the difference between a newly taken sample and said occluding cuff pressure value if the difference is larger, and

(a4) determining that the blood pressure pulse has terminated when a newly taken sample corresponds to the occluding cuff pressure value, with the last up-date of the maximum pressure rise value representing the amplitude of the blood pressure pulse.

5. A method in accordance with claim 1 further including the steps of:

(e) adding together the amplitudes of said predetermined number of blood pressure pulses to derive a sum, and

(f) determining that the systolic pressure has not been validly determined if said sum exceeds a predetermined threshold value.

6. A method in accordance with claim 5 further including the steps of:

(g) forming the difference between successive occluding pressures registered in step (b), and

(h) starting over again if any difference formed in step (g) exceeds a predetermined threshold level.

7. A method in accordance with claim 1 further including the steps of:

(e) forming the difference between successive occluding pressures registered in step (b), and

(f) starting over again if any difference formed in step (e) exceeds a predetermined threshold level.

8. A method in accordance with claim 1 wherein said predetermined number is four, and in step (c) a valid sequence is one which (i) exhibits at least three of its four successive amplitudes not decreasing in value, (ii) has its third amplitude not less than both of its first and second, and (iii) if its third amplitude is greater than its first but not its second, has its fourth as the largest.

9. A method in accordance with claim 8 wherein said predetermined blood pressure pulse is the third in the sequence.

10. A method for determining diastolic pressure as the occluding pressure existing in the cuff of a blood pressure measuring instrument bleeds down; said instrument including means for allowing air in said cuff to bleed out, and means for periodically sampling the instantaneous cuff pressure; comprising the steps of:

(a) utilizing successive samples taken for detecting the presence of sequential blood pressure pulses, and determining the amplitude of each,

(b) registering the occluding pressure in said cuff at the onset of each blood pressure pulse,

(c) deriving a threshold value in accordance with the amplitude information determined in step (a),

(d) adding together the amplitudes of a predetermined number of the last pulses detected to derive a value which is representative of the average amplitude of said predetermined number of last pulses, and comparing said representative value with said threshold value, and

(e) determining the diastolic pressure to be the registered occluding pressure at the onset of a preselected one of said pulses in said predetermined number of last pulses when said representative value is less than said threshold value.

11. A method in accordance with claim 10 wherein said predetermined number is four.

12. A method in accordance with claim 10 wherein said preselected one of said pulses is the second.

13. A method in accordance with claim 10 wherein step (a) includes the sub-steps of:

(a1) maintaining an occluding cuff pressure value and continuously up-dating it in accordance with a newly taken sample if the latter is smaller,

(a2) determining the onset of a blood pressure pulse when a newly taken sample exceeds said occluding cuff pressure value,

(a3) maintaining a maximum pressure rise value after the onset of a blood pressure pulse, and continuously up-dating it in accordance with the difference between a newly taken sample and said occluding cuff pressure value if the difference is larger, and

(a4) determining that the blood pressure pulse has terminated when a newly taken sample corresponds to the occluding cuff pressure value, with the last up-date of the maximum pressure rise value representing the amplitude of the blood pressure pulse.

14. A method in accordance with claim 10 wherein in step (c) the derivation of said threshold value includes the adding together of the amplitudes of a preselected number of successive pulses.

15. A method in accordance with claim 14 wherein the successive pulses whose amplitudes are used in the derivation of said threshold value are those whose sum is the largest.

16. A method in accordance with claim 15 wherein said threshold value includes a constant term which is independent of the amplitudes of said successive pulses.

17. A method in accordance with claim 16 further including the step of:

(f) comparing said largest sum with a fixed value, and

(g) not performing step (e) if said largest sum does not exceed said fixed value.

18. A method in accordance with claim 10 wherein in step (c) said threshold value is derived by adding a constant term to a variable term which is a function of said amplitude information.

19. A method in accordance with claim 18 further including the step of:

(f) comparing said variable term with a fixed value, and

(g) not performing step (e) if said variable term does not exceed said fixed value.

20. A method in accordance with claim 10 further including the steps of:

(f) forming the sum of the amplitudes of a preselected number of the last pulses detected,

(g) comparing the largest sum formed in step (f) with a fixed value, and

(h) not performing step (e) if said largest sum does not exceed said fixed value.

21. A method for determining diastolic pressure as the occluding pressure existing in the cuff of a blood pressure measuring instrument bleeds down; said instrument including means for allowing air in said cuff to bleed out, and means for periodically sampling the instantaneous cuff pressure; comprising the steps of:

(a) utilizing successive samples taken for detecting the presence of sequential blood pressure pulses, and determining the amplitude of each,

(b) registering the occluding pressure in said cuff at the onset of each blood pressure pulse,

(c) deriving a threshold value in accordance with the amplitude information determined in step (a),

(d) comparing amplitude data for a predetermined number of the last pulses detected with said threshold value, said predetermined number being at least one, and

(e) determining the diastolic pressure to be the registered occluding pressure at the onset of a preselected one of said pulses in said predetermined number of last pulses when said amplitude data corresponds with said threshold value.

22. A method in accordance with claim 21 wherein said predetermined number is four.

23. A method in accordance with claim 21 wherein said preselected one of said pulses is the second.

24. A method in accordance with claim 21 wherein step (a) includes the sub-steps of:

(a1) maintaining an occluding cuff pressure value and continuously up-dating it in accordance with a newly taken sample if the latter is smaller,

(a2) determining the onset of a blood pressure pulse when a newly taken sample exceeds said occluding cuff pressure value,

(a3) maintaining a maximum pressure rise value after the onset of a blood pressure pulse, and continuously up-dating it in accordance with the difference between a newly taken sample and said occluding cuff pressure value if the difference is larger, and

(a4) determining that the blood pressure pulse has terminated when a newly taken sample corresponds to the occluding cuff pressure value, with the last up-date of the maximum pressure rise value representing the amplitude of the blood pressure pulse.

25. A method in accordance with claim 21 wherein in step (c) the derivation of said threshold value includes the adding together of the amplitudes of a preselected number of successive pulses.

26. A method in accordance with claim 25 wherein the successive pulses whose amplitudes are used in the derivation of said threshold value are those whose sum is the largest.

27. A method in accordance with claim 26 wherein said threshold value includes a constant term which is independent of the amplitudes of said successive pulses.

28. A method in accordance with claim 27 further including the step of:

(f) comparing said largest sum with a fixed value, and

(g) not performing step (e) if said largest sum does not exceed said fixed value.

29. A method in accordance with claim 21 wherein in step (c) said threshold value is derived by adding a constant term to a variable term which is a function of said amplitude information.

30. A method in accordance with claim 29 further including the step of:

(f) comparing said variable term with a fixed value, and

(g) not performing step (e) if said variable term does not exceed said fixed value.

31. A method in accordance with claim 21 further including the steps of:

(f) forming the sum of the amplitudes of a preselected number of the last pulses detected,

(g) comparing the largest sum formed in step (f) with a fixed value, and

(h) not performing step (e) if said largest sum does not exceed said fixed value.

32. A method for taking blood pressure measurements comprising the steps of:

(a) occluding the artery of a patient with a pressurized occluding cuff and then allowing the pressure in said cuff to bleed down, said cuff being in communication with a pressure transducer which generates samples of the instantaneous cuff pressure,

(b) controlling the generation of samples at a rate high enough to insure that at least several samples are generated during each blood pressure pulse of normal duration,

(c) registering the value of the sample which is generated at the start of a blood pressure pulse, and maintaining it for the duration of at least several but not all of the succeeding blood pressure pulses,

(d) deriving the height of a blood pressure pulse by subtracting the respective value registered in step (c) from the largest sample value for the respective blood pressure pulse, and maintaining said height for the duration of at least several but not all of the succeeding blood pressure pulses, and

(e) utilizing said at least several maintained values of samples and heights for determining blood pressure measurements.

33. A method in accordance with claim 32 wherein the number of maintained values for both samples are heights is substantially less than the number of blood pressure pulses which normally occur during the course of a measurement cycle.

34. A method in accordance with claim 32 wherein said maintained values are utilized to determine systolic pressure.

35. A method in accordance with claim 32 wherein said maintained values are utilized to determine diastolic pressure.

36. A method in accordance with claim 32 wherein in step (e) systolic pressure is determined to be one of the sample values maintained in step (c).

37. A method in accordance with claim 32 wherein in step (e) diastolic pressure is determined to be one of the sample values maintained in step (c).

38. A method in accordance with claim 32 further including the steps of taking a sample while the occluding cuff is at atmospheric pressure to derive a reference value, and causing the sample values processed in the other steps to equal respective generated samples less said reference value.

39. A method in accordance with claim 32 further including means for determining when a sample value is less than a threshold value for aborting a measurement cycle.
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This invention relates to methods and apparatus for the non-invasive detection of arterial blood pressure and pulse rate, and more particularly to instruments which perform the measurements automatically and in a highly reliable manner.

The oldest and most widely used technique for measuring the blood pressure of a patient is to completely occlude an artery by a pressurized cuff whose pressure is then allowed to bleed down. A mercury manometer is used to determine the pressure in the cuff, and a stethoscope is utilized to listen for Korotkoff sounds. The cuff pressures when particular types of sounds are heard are indications of systolic and diastolic pressures. The various methods based on listening for Korotkoff sounds are inherently inaccurate, especially when measuring diastolic pressure since what is required is a determination of the disappearance of sound as it gradually fades out. Even systolic pressure determinations are inaccurate because what is often thought to be a first pressure pulse, and sometimes even a second pressure pulse, are nothing more than artifacts which do not represent a flow of blood through the still fully occluded artery. A mean error of .+-.8 mm Hg can be expected in readings of systolic and diastolic pressures based on Korotkoff sounds. (Best and Taylor, Physiological Basis of Medical Practice, 9th Edition, Chapter 7, page 3-151.) Nor are present-day automatic instruments based on Korotkoff sounds any more reliable. Not only is it difficult to monitor electronically a fading sound, but the methodologies employed do not provide consistent, reliable results.

Other measurement approaches have met with equally little success. With respect to oscillometric methods, it is very difficult to determine diastolic pressure because one has to look for changes in oscillations of a mercury column, and they are barely noticeable with narrow-width pressure pulses. Hot-wire anemometer-type transducers offer somewhat better accuracy, but they require the use of two cuffs (occluding and sensing, in which the pressure in the sensing cuff is maintained constant). One of the shortcomings of these and other prior art devices is that two transducers and associated electronics are required.

Representative prior art, in addition to the Best and Taylor text referred to above, are the following:

__________________________________________________________________________ Patent No. Date Inventor Title __________________________________________________________________________ 2,827,040 March 18, 1958 S.R. Gilford Automatic Sphygmomanometer 3,224,435 Dec. 21, 1965 M. Traite Method of Measuring Blood Pressure 3,229,685 Jan. 18, 1966 D.L. Ringkamp Blood Pressure et al Measuring 3,480,005 Nov. 25, 1969 W.C. Edwards Apparatus for Measuring Blood Pressure With Plural Brake Controlled Indicators 3,581,734 June 1, 1971 M.E. Croslin et al Sphygmomanometer 3,742,937 July 3, 1973 B. Manuel et al Cardiac Monitor 3,742,938 July 3, 1973 T.J. Stern Cardiac Pacer and Heart Pulse Monitor 3,814,083 June 4, 1974 J.C. Fletcher Apparatus and Method et al FOr Processing Korotkov Sounds 3,841,314 Oct. 15, 1974 R.E. Page Pulse Activity Indicator 3,885,551 May 27, 1975 H.L. Massie Artifact Rejection For Blood Pressure Monitoring 3,894,533 July 15, 1975 R.L. Cannon Vital Sign Trend Intuitive Display System 3,903,872 Sept. 9, 1975 W.T. Link Apparatus and Pro- cess For Producing Sphygmometric Infor- mation 3,978,848 Sept. 7, 1976 D.H. Yen et al Monitoring Apparatus And Method For Blood Pressure and Heart Rate 4,009,709 March 1, 1977 W.T. Link et al Apparatus and Pro- cess For Determining Systolic Pressure 4,047,711 Feb. 21, 1978 W.T. Link et al Apparatus And Pro- cess For Determining Systolic Pressure __________________________________________________________________________ Other Publications: 1. L.A. Geddes et al "The Meaning of the Point of Maximum Oscillations i Cuff Pressure in the Indirect Measurement of Blood Pressure, Part I", Cardiovascular Research Center Bulletin, July-Sept., 1969, pages 15-25. 2. Physiological Basis of Medical Practice, Ninth Edition, John R. Brobeck: Chapter 7, Section 3 "Measurement of Blood Pressure and Flow", pages 148-163; Chapter 8, Section 3 "Control Mechanisms of the Circulatory System", pages 164-188; Chapter 9, Section 3 "Regulation of Systemic and Pulmonary Circulation", pages 189-210. 3. George E. Burch "Sphygmomanometric Cuff Size and Blood Pressure Recordings", JAMA, 3 Sept. 1973, Vol. 225, No. 10, pages 1215-1218. 4. Electronic Design, Vol. 24, No. 19, September 13, 1976, page 28, "Semi invade medical transducers; microprocessors monitor EKG and blood pressure". 5. "Computer Automation of BloodPressure Measurements", Proceedings of th IEEE, Vol. 63, No. 10, October 1975, pages 1399-1403.

The basic problem with most prior art automated blood pressure measuring instruments is that they look for "gross" indications, e.g., the presence of a pulse based upon a sound level or some other parameter reaching a detectable level. From a theoretical standpoint, the most accurate measurement determinations could be made were the pressure waveform in the cuff actually traced out on paper during the course of a measurement cycle, much as is done in the case of ECG waveform analysis. The pressure waveform would show a decreasing occluding cuff pressure, on which blood pressure pulses are superimposed. Such a paper trace would provide to the physician the maximum amount of information from which systolic and diastolic pressures could be determined. If a trace is not to be made and an instrument is to perform the analysis, then ideally the processing section of the instrument should be provided with the exact waveform of the pressure in the cuff. It is possible to do this by sampling the cuff pressure at a sufficiently high rate and to then process the samples. If the sampling rate is so high that numerous samples are taken during the occurrence of each pulse, then from the standpoint of information theory the processing section of the instrument will have available sufficient data from which the complete waveform may be reconstructed.

However, while this general principle may have been recognized by prior art researchers, they have not employed effective methodologies in analyzing the sampled data. One problem in this regard is that the analysis must be done "on the fly". In the illustrative embodiment of the invention, a sample is taken approximately every 2.5 milliseconds; thus 400 samples are taken each second, and an 8 k memory would be required to store the data for a measurement cycle of 20 seconds--if all of the data is to be stored prior to the actual processing which determines the final measurement values. A cost-effective instrument must therefore perform the processing as samples are taken without storing a complete history of the pressure waveform. The methodologies employed in the prior art for performing this type of "on-the-fly" processing have not provided accurate or consistent results.

For example, consider the methodology for systolic pressure determination disclosed in Link et al U.S. Pat. No. 4,009,709. Link et al theorize that the DC pressure in the cuff (the value of the slowly changing occluding pressure) when there is detected a blood pressure pulse whose amplitude is one-half of a maximum amplitude value represents the systolic pressure, where the maximum amplitude value is the maximum average amplitude over four successive pulses. In the Link et al instrument, a "sliding average" of the pulse amplitude over four successive pulses is taken, and a threshold level is constantly up-dated to equal the maximum sliding average. Link et al pump up the pressure continuously. As the occluding pressure increases, the pulse amplitudes rise and then fall. By using an increasing pressure during the measurement cycle, maximum pulse amplitudes are detected before the occluding pressure reaches the relatively high value which represents systolic pressure. It is in this way that the threshold level is determined before a pulse is actually detected whose amplitude is less than one-half of the threshold level. The Link et al technique requires a smooth pump-up of the cuff pressure and thus does not allow a cheap, conventional-type manually-operated bulb pump to be used. On the other hand, it is possible to use a bulb to pump up the pressure to a value which completely occludes the artery, and then to allow the pressure to bleed down smoothly as in conventional instruments. But in such a case, the systolic pressure is reached before the threshold level can even be determined. This, in turn, requires that a considerable amount of data be stored since "on-the-fly" processing is possible to only a limited extent.

But quite apart from the difficulties in implementing such a technique, the Link et al methodology has not proven to provide consistently correct systolic pressure measurements. The basic premise of Link et al is that the systolic pressure is the DC cuff pressure when a particular pulse is detected, and that particular pulse is the first one in a decreasing amplitude sequence whose amplitude corresponds to one-half of the maximum amplitude (or, more accurately, the maximum average amplitude over four successive pulses). This criterion has not been established, but even were it valid the Link et al system does not take into account the existence of artifacts. For example, if a patient moves his arm during the course of a measurement cycle and in the process squeezes the cuff, there will be a very large pressure rise which may control the maximum average pulse amplitude which is used as the threshold value--the threshold value and therefore the systolic pressure determination being completely erroneous in such a case.

What is important in an automated blood pressure measurement instrument is not only the selection of the proper criteria for determining systolic and diastolic pressures, but also validation of the results. Throughout the following detailed description of the invention, it will be noted that considerable attention is paid to validating the measurement cycle. One such example is the analysis of each individual pulse; a pulse is not considered to be valid if its amplitude is too large. Another example relates to the determination of systolic pressure. The sequence of pulse amplitudes in the region of systolic pressure must be one of plurality of predetermined valid sequences. It is this kind of constant concern for validating the measurement results (both intermediate and final) which contributes to reliable instrumentation.

In the illustrative embodiment of the invention a display is provided for guiding the operator--physician or patient--through the measurement cycle. As the bulb is used to pump up the cuff pressure, the operator is informed not only of the instantaneous cuff pressure, but also of the particular actions which are required. This, in and of itself, is an important feature of the invention. Furthermore, for a measurement cycle to provide accurate results, it is essential that the artery be completely occluded before the cuff pressure is monitored for the presence of pulses. What the system of the invention does is to check that no pulses have been detected for about 2.5 seconds before it assumes that the artery has been completely occluded and the cuff pressure should be allowed to continue bleeding down. If full occlusion for 2.5 seconds is not ascertained, the display informs the operator to pump up the cuff pressure.

The basic systolic pressure methodology involves an analysis of the amplitudes of four successive pulses, when pulses first appear as the occluding pressure bleeds down. (As will be described below, artifacts are rejected and it is not necessarily the first four pulse amplitudes which are operated upon.) Systolic pressure is taken to be the cuff pressure at the onset of a particular one of the four pulses, but only if the pulse amplitudes have a sequence which is one of a plurality of known valid sequences, e.g., four successive pulses exhibit increasing amplitudes, except for the third which may have the largest amplitude. There are quite a few valid sequences, some of which will be described in detail below.

The diastolic pressure methodology is actually similar to the Link et al methodology for determining systolic pressure. (There is no apparent reason why the same type of methodology should be effective to determine both systolic and diastolic pressures; in fact, it is not effective for systolic pressure determinations as taught by Link et al, but it is effective for diastolic pressure determinations.) A threshold value is determined based upon maximum pulse amplitude information; in the illustrative embodiment of the invention, the threshold level partially depends upon the maximum average pulse amplitude over four pulses. But the threshold value is not based solely upon the maximum amplitude information; it is also a function of a constant value. Moreover, instead of comparing the amplitude of a single pulse with the threshold value in order to determine diastolic pressure, the comparison involves the average pulse amplitude over four pulses in the vicinity of diastolic pressure.

The methodology of the invention does not lend itself to a more detailed general description. Suffice it to say that the method of the invention allows "on-the-fly" analysis of samples taken at a sufficiently high rate such that they allow the complete cuff pressure waveform to be reproduced. The criteria for determining systolic and diastolic pressures have proved to be accurate and reliable. Throughout the processing, validation checks are performed. Any indication of erroneous measurements having been taken results in an appropriate error message. Accurate measurements of pulse rates are also provided. In connection with a pulse rate measurement, while it is not particularly difficult to count detected pulses (as is known in the prior art), it is the rejection of a measurement cycle due to the presence of artifacts that gives rise to the high accuracy of my method and apparatus.

Further objects, features and advantages of my invention will become apparent upon consideration of the following detailed description in conjunction with the drawing, in which:

FIG. 1 is a perspective view of the instrument of my invention;

FIG. 2 depicts a portion of the circuit board within the housing of the instrument, and several of the components mounted on the board;

FIGS. 3-6 are a schematic of the circuit of the instrument, with the figures being arranged as shown in FIG. 7;

FIG. 8 depicts two resistor networks utilized in the circuit of FIGS. 3-6;

FIG. 9 depicts the seven segments of each display element, together with the fifteen characters which can be formed by energizing appropriate ones of the segments (the 16th character is a blank, obtained by energizing none of the segments);

FIGS. 10-13, 15-18, 20, 23 and 24 are flow charts depicting most of the method of my invention, and should be read in conjunction with the complete source listing which is reproduced below and which will be described;

FIG. 14, which is not drawn to scale, depicts the cuff pressure throughout a measurement cycle;

FIG. 19 depicts, in enlarged scale, the cuff pressure in the vicinity of a single blood pressure pulse;

FIG. 21 depicts the envelope of the pulse amplitudes--not the cuff pressure, but just the amplitudes of individual pulses such as that shown in FIG. 19--throughout a measurement cycle; and

FIG. 22 depicts several illustrative pulse sequences which will be discussed in conjunction with the systolic pressure measurement methodology.

Hardware

FIG. 1 depicts the instrument of my invention. It includes a conventional cuff 40, with tubing 42 connecting the cuff to pump-up bulb 44. As the bulb is pumped, the pressure in the cuff rises. There is a bleed valve 45 in the bulb which allows air in the cuff to bleed out at a rate of several mm Hg per second, the actual bleed rate depending upon the cuff pressure. Tubing 47 connects the cuff to a manifold within the instrument housing. The overall cuff arrangement is standard except that the take-off tubing 47 is extended to the instrument rather than to a mercury column as in conventional blood pressure measuring instruments.

The instrument itself includes three switches and a twelve-character display DP1 (under a red translucent strip 43). Switch S1 (on the top) is the main on/off switch which, when operated, connects the internal batteries to the circuit. (The unit also includes a jack 49 for insertion of the plug of a charging circuit when it is necessary to recharge the batteries.) Switch S2 is the reset/exhaust switch which is spring-loaded to an open position. When it is momentarily closed, as will be described below, the instrument resets and initiates a new cycle of operation. Switch S3, another normally-open, spring-loaded push-button, is the recall/cuff control. When it is operated, one of two different sequences takes place depending upon the state of the instrument at the time the button is operated. Toward the beginning of the overall cycle, operation of switch S3 closes take-off tubing 47 as will be described shortly, so that the pressure in the cuff can be pumped up by repeatedly squeezing bulb 44. At the end of a measurement cycle, the final values are displayed for only ten seconds, also as will be described below, and the display is then blanked to conserve power. Operation of switch S3 causes the previously determined values to be displayed once again, for another ten seconds.

The display itself consists of 12 character positions, each of which has seven light-emitting diode segments as shown at the left of FIG. 9. Depending upon which of the segments are energized, any one of 15 characters can be displayed at each position, the 15 characters also being shown in FIG. 9 and it being obvious which of the seven segments are used to form each of the fifteen characters. A blank may be displayed simply by energizing no segments. The display elements are also used to form numerals as is well known in the art.

The instrument also includes a light-emitting diode LD1 (under a red translucent area 51 on the case) which, when illuminated, represents one of two things. First, the light is on whenever the system is in the process of detecting a blood pressure pulse (a rise in the occluding cuff pressure). Second, after the final display has been blanked in order to conserve power, the light is turned on to indicate to the operator that the display can be recalled if switch S3 is momentarily operated. Lastly, the positions on the display of the final measurement values are printed on the case.

FIG. 2 depicts just one part of the circuit board 18 on which the circuit components are mounted within the housing. Switch S3 can be seen in the drawing. In addition, a manifold 20 is mounted on the board, and spaced from it by spacer 22. The manifold provides open communication between input pipe 24 (on which take-off tubing 47 of FIG. 1 is placed), a pipe segment 26, and a valve V1. The valve is normally open, but when its two leads (not shown) have a potential applied across them, the valve closes. A pressure transducer T1 is mounted on the other side of the board--the side on which all of the chips used in the circuit are mounted--and the input port of the transducer is connected to pipe segment 26. It is apparent that since pipe 24 is connected via take-off tubing 47 to the cuff, transducer T1 has as its "input" the cuff pressure. Valve V1 is used to open the cuff to the atmosphere, within and through the housing, so that the cuff pressure can rapidly decrease at the end of a measurement cycle. The valve is closed automatically by the circuit after switch S3 is operated so that the pump-up procedure can commence. It is important to note that transducer T1 is located within the instrument housing and is not positioned in the cuff (although it could be). Thus there are no circuit elements which are in contact with the patient.

The schematic of the circuit is shown in FIGS. 3-6. Many of the chips are identified on the schematic, and the omitted chip identifications, as well as the component values, are as follows (many of the resistors are contained in four resistor networks, identified by the symbols RA1-RA4, which will be discussed below):

______________________________________ C1 22uf R18* 15K RA(1) C2 .01uf R19 10K C3 6.8uf R20 2K C4 6.8uf R21* 20K (RA1) C5 .01uf R22 1K C6 .47uf R23* 5K (RA2) C7 .01uf R24 100 C8 .01uf R25* 10K (RA1) C9 22uf R26 100 C10 .01uf R27* 7.5K (RA1) C11 .47uf R28* 402K (RA1) C12 .01uf R29* 10K (RA1) C13 .47uf R30* 330 (RA4) C14 .01uf R31* 10K (RA1) C15 10f R32* 330 (RA4) C16 22uf R33* 330 (RA4) C17 .47uf R34* 330 (RA4) C19 1uf R35* 162K (RA1) C20 1uf R36* 40.2K (RA1) C21 .01uf R37* 4.7K (RA3) C22 270pf R38* 4.7K (RA3) C23 68pf R39* 4.7K (RA3) C24 20pf R40* 4.7K (RA3) C25 20pf R41 47 (1/2W) C26 .1uf RA1 Custom 16-Pin Dip, 1% C27 .1uf RA2 Custom 16-Pin Dip, 1% R1* 18.7K (RA2) RA3 Bourns 4310R-102-472 R2* 19.6K (RA2) (10-Pin Sip), 1% R3* 1M (RA2) RA4 Bourns 4310R-102-331 R4* 10K (RA2) (10-Pin Sip), 1% R5* 18.7K (RA2) D1 IN4001 R6* 1M (RA2) D2 IN4001 R7* 10K (RA2) D6 1N4001 R8* 21.5K (RA2) Z1 1N5523 R9 1K IC3 LM324 R1