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Electronic sphygmomanometer    

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United States Patent4313445   
Link to this pagehttp://www.wikipatents.com/4313445.html
Inventor(s)Georgi; Heinz W. (Del Mar, CA)
AbstractAn electronic method and apparatus for automatically determining systolic and diastolic blood pressure and heart rate by accurately detecting, verifying and evaluating the full stream of korotkoff sounds produced as electrical signals from a microphone in a cuff occluding the brachial artery of a patient. Waveform analysis is first performed upon the incoming signal waveforms by an analog prescreening subsystem to initially separate true korotkoff sound signals from a variety of artifact and noise signals and to provide an output pulse stream correctly indicating korotkoff sound occurrences in the time and blood pressure domain, with each pulse proportional in amplitude to the amplitude of the corresponding korotkoff sound represented. The output korotkoff sound pulse stream is then digitized by an analog to digital converter and further analyzed by a digital processing subsystem to additionally remove any noise and artifact signals passed as otherwise misleading quasi-korotkoff sound pulses by the prescreening subsystem, to modify and certify the resultant data as either reliable or suspect, to determine heart rate and the most probable values for systolic and diastolic blood pressure levels indicated by the signal stream detected during the measurement cycle.
   














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Drawing from US Patent 4313445
Electronic sphygmomanometer - US Patent 4313445 Drawing
Electronic sphygmomanometer
Inventor     Georgi; Heinz W. (Del Mar, CA)
Owner/Assignee     IVAC Corporation (San Diego, CA)
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Publication Date     February 2, 1982
Application Number     05/845,081
PAIR File History     Application Data   Transaction History
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Filing Date     October 25, 1977
US Classification     600/493 600/495
Int'l Classification     A61B 005/02
Examiner     Michell; Robert W.
Assistant Examiner     Jaworski; Francis J.
Attorney/Law Firm     Fulwider, Patton, Rieber, Lee & Utecht
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USPTO Field of Search     128/677 128/678 128/679 128/680 128/681 128/682 128/683 128/684 128/685 128/686 128/677 128/678 128/679 128/680 128/681 128/682 128/683 128/684 128/685 128/686
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I claim:

1. In an electronic sphygmomanometer, the combination comprising:

means for providing detected korotkoff sounds and associated korotkoff sound precursors as electrical signals, each of said korotkoff sound precursors being included in the waveforms relating solely to the individual korotkoff sound signal with which that precursor is associated; and

means for analyzing the waveforms of all said electrical signals to determine selectively the presence of specified korotkoff sound precursors and the conformity of such precursors with predetermined waveform characteristics, whereby those electrical signals having waveforms representative of true korotkoff sounds are separated from those electrical signals which do not represent true korotkoff sounds.

2. A combination as set forth in claim 1, wherein said means for analyzing said waveforms includes a diastolic channel, a systolic channel and an amplitude channel, the electrical output from said amplitude channel being selectively gated by either of said diastolic channel and said systolic channel.

3. A combination as set forth in claim 2, wherein said diastolic channel evaluates the amplitude of a waveform precursor to a korotkoff spike.

4. A combination as set forth in claim 2, wherein said diastolic channel evaluates the area of a waveform precursor to a korotkoff spike.

5. A combination as set forth in claim 2, wherein said diastolic channel evaluates the time duration of a waveform precursor to a korotkoff spike.

6. A combination as set forth in claim 2, wherein said diastolic channel evaluates the amplitude, area and time duration of a waveform precursor to a korotkoff spike.

7. A combination as set forth in claim 2, wherein said systolic channel evaluates the slope of the leading edge of a korotkoff spike.

8. A combination as set forth in claim 2, wherein said systolic channel evaluates the duration of the leading edge of a korotkoff spike.

9. A combination as set forth in claim 2, wherein said systolic channel evaluates the slope and time duration of the leading edge of a korotkoff spike.

10. The combination as set forth in claim 2, wherein said amplitude channel measures the amplitude of a korotkoff spike.

11. The combination as set forth in claim 10, wherein said amplitude channel measures said amplitude along the trailing edge of said korotkoff spike.

12. A combination as set forth in claim 1, wherein said means for analyzing said waveforms includes:

means for measuring the amplitude, area and time duration of a waveform precursor to a korotkoff spike; and

means for measuring the slope and time duration of the leading edge of a korotkoff spike.

13. In an electronic sphygmomanometer for analyzing korotkoff sounds produced by an auscultation blood pressure measuring process, the combination comprising:

first means for providing korotkoff sounds and associated korotkoff sound precursors as input electrical signals, each of said korotkoff sound precursors being included in the waveforms relating solely to the individual korotkoff sound signal with which that precursor is associated;

second means for analyzing the waveforms of all of said input electrical signals to determine selectively the presence of specified korotkoff sound precursors and their conformity with predetermined waveform characteristics; and

third means responsive to said second means for selectively producing output electrical signals in time correlation only with those input electrical signals corresponding to true korotkoff sounds, whereby those input electrical signals representing true korotkoff sounds are separated from artifact and noise signals.

14. A combination as set forth in claim 13, wherein said third means produces output electrical signals proportional in amplitude to those input electrical signals representing true korotkoff sounds.

15. A combination as set forth in claim 13, wherein said second means analyzes the amplitude of portions of said waveform.

16. A combination as set forth in claim 13, wherein said second means analyzes the area of portions of said waveform.

17. A combination as set forth in claim 13, wherein said second means analyzes the time duration of portions of said waveform.

18. An electronic sphygmomanometer as set forth in claim 17, and further including:

first means for rectifying the waveforms of each of said input electrical signals;

second means for integrating the area under the rectified waveform produced by said first means.

19. Apparatus as set forth in claim 18, wherein said means for integrating the area requires that a minimum amplitude threshold be exceeded to begin integration.

20. Apparatus as set forth in claim 18, wherein said means for integrating the area requires a minimum time period for the electrical output of the integration to exceed a predetermined level.

21. Apparatus as set forth in claim 18, and further including:

discrimination means for measuring the magnitude of the electrical output from said second means.

22. A combination as set forth in claim 13, wherein said second means analyzes the slope of portions of said waveform.

23. An electronic sphygmomanometer, comprising:

input means for providing korotkoff sounds and associated korotkoff sound precursors as input electrical signals, each of said korotkoff sound precursors being included in the waveforms relating solely to the individual korotkoff sound signal with which that precursor is associated;

waveform analysis means for receiving and analyzing the waveforms of all of said input electrical signals to determine selectively the presence of specified korotkoff sound precursors and the conformity of each individual input electrical signal with predetermined waveform characteristics and to produce an electrical output indicative of the presence or absence of such conformity, and thereby the presence or absence of said specified precursors, for each such input electrical signal; and

output means responsive to said electrical output from said waveform analysis means for producing output electrical signals indicative of only those input electrical signals having waveforms representative of the occurrence of true korotkoff sounds.

24. A sphygmomanometer as set forth in claim 23, wherein said waveform analysis means measures the conformity of input electrical signals with characteristics of a first class of generalized waveforms.

25. An electronic sphygmomanometer as set forth in claim 24, wherein said waveform analysis means also measures the conformity of said input electrical signals with the characteristics of a second class of generalized waveforms.

26. An electronic sphygmomanometer as set forth in claim 23, wherein said waveform analysis means measures the conformity of said input electrical signals with characteristics of a plurality of classes of generalized waveforms.

27. An electronic sphygmomanometer as set forth in claim 23, wherein said waveform analysis means includes means for evaluating the amplitude, area and time duration of a waveform precursor occurring immediately prior to a korotkoff spike and of opposite polarity from said spike.

28. An electronic sphygmomanometer as set forth in claim 23, wherein said waveform analysis means includes means for evaluating the time duration and minimum slope of the leading edge of a korotkoff spike.

29. An electronic sphygmomanometer as set forth in claim 28, and further including:

rectifier means for rectifying the waveforms of all of said input electrical signals;

means for differentiating the electrical output of said rectifier means;

discriminator means for measuring the amplitude of electrical outputs from said differentiator means; and

timing means for measuring the duration of electrical output from said discriminator means.

30. An electronic sphygmomanometer as set forth in claim 23, wherein said output means measures the amplitude of each korotkoff spike occurring in an input electrical waveform and produces an output electrical signal having an amplitude proportional to the base to peak amplitude of said spike.

31. An electronic sphygmomanometer as set forth in claim 30, wherein said amplitude is measured along the trailing edge of said korotkoff spike.

32. An electronic sphygmomanometer as set forth in claim 30, and further including:

first rectifier means for rectifying the waveforms of all of said input electrical signals;

differentiator means for differentiating the electrical output of said first rectifier means;

second rectifier means for rectifying the electrical output of said differentiator means; and

integration means for integrating the electrical output of said rectifier means.

33. Apparatus as set forth in claim 32, wherein said second rectifier means isolates the trailing edge of each korotkoff spike.

34. Apparatus as set forth in claim 32, wherein said integration means produces output electrical pulses proportional in amplitude to the base to peak amplitude of each korotkoff spike.

35. Apparatus as set forth in claim 34, wherein said amplitude is measured along the trailing edge of each korotkoff spike.

36. An electronic sphgmomanometer as set forth in claim 32 and further including:

gating means under the control of said waveform analysis means for selectively passing electrical output as pulses from said second rectifier means to said integration means.

37. Apparatus as set forth in claim 36, wherein said gating means enables passage of electrical output from said rectifier means to said integration means only when said waveform analysis means produces an electrical output indicative of the presence of conformity between said input electrical signals and said predetermined waveform characteristics.

38. Apparatus as set forth in claim 36, and further including:

control means for controlling the output of said gating means in response to a variable amplitude threshold applied to said pulses.

39. Apparatus as set forth in claim 38, wherein said variable threshold prevents passage of relatively small pulses for a period of time after passage of relatively larger pulses.

40. Apparatus as set forth in claim 38, wherein said control means includes a peak rectifier electrical circuit.

41. Apparatus as set forth in claim 40, wherein said control means includes a discriminator latch and said gating means is enabled and disabled in accordance with the electrical output state of said latch.

42. Apparatus as set forth in claim 41, wherein said peak rectifier receives an electrical input from said output means.

43. Apparatus as set forth in claim 38, wherein said control means includes a discriminator latch circuit.

44. Apparatus as set forth in claim 38, wherein said control means includes both a peak rectifier and discriminator latch.

45. An electronic sphygmomanometer as set forth in claim 23, wherein said waveform analysis means includes a first channel for evaluating the amplitude, area and time duration of a waveform precursor to a korotkoff spike and a second channel for evaluating the slope and time duration of the leading edge of a korotkoff spike.

46. An electrical sphygmomanometer, comprising:

first means for providing electrical waveforms representing korotkoff sounds and associated korotkoff sound precursors, each of said korotkoff sound precursors being included in the waveforms relating solely to the individual korotkoff sound signal with which that precursor is associated;

second means for analyzing the amplitude selectively of portions of said waveforms and producing an output pulse stream representative of the amplitude and occurrence of those of said waveforms representing true korotkoff events;

third means for determining selectively the presence of specified korotkoff sound precursors by the correlation of said electrical waveforms with prescribed waveform conditions;

fourth means for controlling the output of said first means in response to waveform analysis by said second means; and

fifth means for analyzing the electrical output of said first means to determine blood pressure.

47. An electronic sphygmomanometer as set forth in claim 46, wherein said fifth means also determines heart rate.

48. Apparatus as set forth in claim 46, wherein said first means, said second means, said third means and said fourth means are analog electrical systems.

49. Apparatus as set forth in claim 46, wherein said fifth means is a digital system.

50. Apparatus as set forth in claim 46, wherein said first means, said second means, said third means, and said fourth means are analog systems and said fifth means is a digital system.

51. In an electronic sphygmomanometer for analyzing korotkoff sounds produced by an auscultation blood pressure measuring process, the combination comprising:

first means for providing korotkoff sounds and associated korotkoff sound precursors as input electrical signals, each of said korotkoff sound precursors being included in the waveforms relating solely to the individual korotkoff sound signal with which that precursor is associated;

second means for prescreening selectively for the presence of specified korotkoff sound precursors the waveforms of all of said input electrical signals from said first means and producing output electrical signals in time correlation only with those input electrical signals corresponding to the occurrence of true korotkoff events; and

third means for analyzing the output electrical signals from said second means to determine blood pressure.

52. Apparatus as set forth in claim 51, wherein said third means further screens said output electrical signals to eliminate those electrical signals representing events other than the occurrence of true korotkoff events.

53. Apparatus as set forth in claim 51, wherein said second means is an analog system.

54. Apparatus as set forth in claim 51, wherein said third means is a digital system.

55. Apparatus as set forth in claim 54, wherein said second means includes a diastolic channel, a systolic channel and an amplitude channel.

56. Apparatus as set forth in claim 55, wherein said diastolic channel evaluates the amplitude, area and time duration of a waveform precursor to a korotkoff spike.

57. Apparatus as set forth in claim 55, wherein said systolic channel evaluates the slope and time duration of the leading edge of a korotkoff spike.

58. Apparatus as set forth in claim 55, wherein said amplitude channel measures the amplitude of a korotkoff spike.

59. Apparatus as set forth in claim 58, wherein said amplitude channel measures said amplitude along the trailing edge of said korotkoff spike.

60. Apparatus as set forth in claim 51, wherein said third means also determines heart rate.

61. Apparatus as set forth in claim 51, wherein said second means is an analog system and said third means is a digital system.

62. An electronic sphygmomanometer, comprising:

first means for detecting electrical waveforms representing korotkoff sounds and producing output pulses representing said korotkoff sounds;

second means for controlling the output of said first means in response to a variable amplitude threshold applied to said pulses.

63. Apparatus as set forth in claim 62, wherein said variable threshold prevents passage of relatively small pulses for a period of time after passage of relatively larger pulses.

64. Apparatus as set forth in claim 63, wherein said peak rectifier receives an electrical input from said first means.

65. Apparatus as set forth in claim 62, wherein said second means includes a peak rectifier electrical circuit.

66. Apparatus as set forth in claim 62, wherein said second means includes a discriminator latch circuit.

67. Apparatus as set forth in claim 62, wherein said first means includes a control gate.

68. Apparatus as set forth in claim 67, wherein said second means includes a discriminator latch and said control gate is enabled and disabled in accordance with the electrical output state of said latch.

69. Apparatus as set forth in claim 63, wherein said second means includes both a peak rectifier and discriminator latch.

70. Apparatus as set forth in claim 62, wherein said first means includes a control gate, said second means includes a peak rectifier and discriminator latch, and said control gate is opened and closed to respectively pass and block the output pulses from said first means in accordance with the electrical output state of said latch.

71. An electronic sphygmomanometer, comprising:

first means for providing electrical waveforms representing korotkoff sounds and associated korotkoff sound precursors, each of said korotkoff sound precursors being included in the waveforms relating solely to the individual korotkoff sound signal with which that precursor is associated;

second means for analyzing the amplitude selectively of portions of said waveforms and producing an output pulse stream representing the amplitudes and occurrences of those of said waveforms representing true korotkoff events;

and third means for determining selectively the presence of specified korotkoff sound precursors by the correlation of said electrical waveforms with prescribed waveform characteristics and for controlling the output of said second means in response to the waveform analysis of said third means.

72. Apparatus as set forth in claim 71, and further including:

fourth means for frequency shaping the electrical input to said second means.

73. Apparatus as set forth in claim 71, and further including:

fifth means for frequency shaping the electrical input to said third means.

74. Apparatus as set forth in claim 73, wherein said fifth means provides a pass band substantially in the range from 1/2 Hz. to 20 Hz.

75. Apparatus as set forth in claim 72, wherein said fourth means provides a first pass band substantially in the range from 15 Hz. to 150 Hz. and a second pass band substantially in the range from 1/2 Hz. to 10 Hz., said second pass band being attenuated relative to said first pass band.

76. In an electronic sphygmomanometer, the combination comprising:

first means for determining the amplitude selectively of the trailing edge of a korotkoff signal spike and producing an output pulse proportional thereto;

second means for correlating and measuring the amplitude, area and time duration selectively of a precursor bulge preceding a korotkoff spike;

third means for correlating and measuring the slope and time duration selectively of a leading edge of a korotkoff spike; and

fourth means responsive to an indication of successful correlation from either of said second means and said third means for selectively enabling said first means.

77. A combination as set forth in claim 76, wherein said second means is a diastolic waveform analysis means.

78. A combination as set forth in claim 76, wherein said third means is a systolic waveform analysis means.

79. A combination as set forth in claim 76, wherein said first means includes a control gate for selectively passing or blocking the output pulses from said first means.

80. A combination as set forth in claim 76, and further including;

fifth means for selecting enabling said first means in response to a variable amplitude threshold applied to each output pulse from said first means.

81. Apparatus as set forth in claim 80, wherein said variable amplitude threshold prevents passage of relatively small output pulses from said first means for a period of time after the passage of a relatively larger output pulse from said first means.

82. A combination as set forth in claim 76, wherein said first means provides electrical input to an integrator within said first means.

83. Apparatus as set forth in claim 82, and further including:

fifth means for selectively enabling said first means and simultaneously controlling charging and discharging of said integrator.

84. Apparatus as set forth in claim 83 wherein said fifth means includes a discriminator latch.

85. Apparatus as set forth in claim 83, wherein said fifth means includes a peak rectifier and discriminator latch circuit and said peak rectifier receives an electrical input from said first means.

86. Apparatus as set forth in claim 82, and further including:

fifth means for controlling the electrical output of said first means in response to a variable amplitude threshold applied to electrical output pulses from said first means and also controlling, charging and discharging of said integrator.

87. A combination as set forth in claim 76, wherein the electrical input to said first means is frequency shaped to provide a first pass band substantially in the range of 15 Hz. to 150 Hz. and a second pass band substantially in the range of 1/2 Hz. to 10 Hz., said second pass band being attenuated relative to said first pass band.

88. A combination as set forth in claim 76, wherein the electrical input to said second means and said third means is frequency shaped to provide a pass band substantially in the range of 1/2 Hz. to 20 Hz.

89. In a method of blood pressure measurement, the steps of:

providing electrical input waveform signals representing korotkoff sounds and associated korotkoff sound precursors, each of said korotkoff sound precursors being included in the waveforms relating solely to the individual korotkoff sound signal with which that precursor is associated; and

analyzing the waveforms of all of said signals to determine selectively the presence of specified korotkoff sound precursors and the conformity of such precursors with predetermined waveform characteristics, whereby those waveforms representative of true korotkoff sounds are separated from those waveforms which do not represent true korotkoff sounds.

90. A method as set forth in claim 89, wherein said analyzing step includes:

measuring the amplitude of a waveform precursor to a korotkoff spike.

91. A method as set forth in claim 89, wherein said analyzing step includes:

measuring the area of a waveform precursor to a korotkoff spike.

92. A method as set forth in claim 89, wherein said analyzing step includes:

measuring the time duration of a waveform precursor to a korotkoff spike.

93. A method as set forth in claim 89, wherein said analyzing step includes:

measuring the slope of the leading edge of a korotkoff spike.

94. A method as set forth in claim 89, wherein said analyzing step includes:

measuring the time duration of the leading edge a korotkoff spike.

95. A method as set forth in claim 89, wherein said analyzing step includes:

measuring the amplitude of a korotkoff spike.

96. A method as set forth in claim 89, wherein said analyzing step includes:

measuring the amplitude of a korotkoff spike along the trailing edge of the korotkoff spike.

97. In an electronic sphygmomanometer, the combination comprising:

first means for determiming the amplitude selectively of the trailing edge of a korotkoff signal spike and producing an output pulse proportional thereto;

second means for correlating and measuring the amplitude, area and time duration selectively of a precursor bulge preceding a korotkoff spike;

third means responsive to an indication of successful correlation from said second means for selectively enabling said first means.

98. In an electronic sphygmomanometer, the combination comprising:

first means for determining the amplitude selectively of the trailing edge of a korotkoff signal spike and producing an output pulse proportional thereto;

second means for correlating and measuring the slope and time duration selectively of a leading edge of a korotkoff spike; and

third means responsive to an indication of successful correlation from said second means for selectively enabling said first means.

99. In an electronic sphygmomanometer, the combination comprising:

first means for correlating and measuring the amplitude, area and time duration selectively of a precursor bulge preceding a korotkoff spike; and

second means for correlating and measuring the slope and time duration selectively of a leading edge of a korotkoff spike.
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BACKGROUND OF THE INVENTION

This invention relates generally to improvements in methods and apparatus for the measurement of blood pressure and heart rate and, more particularly, to a new and improved electronic sphygmomanometer system enabling very rapid, accurate, reliable and easily obtained blood pressure and heart rate measurements.

It is common practice in the medical arts, as in hospitals and doctors' offices, to employ an auscultation technique for measuring the blood pressure of a patient by using the characteristics of the so-called korotkoff sounds to determine the systolic and diastolic values of the patient's blood pressure.

The korotkoff method typically makes use of an inflatable cuff surrounding a portion of the patient's upper arm. Sufficient inflation of the cuff closes off or completely occludes the brachial artery of the patient. As air is released and the cuff is slowly deflated, a point is reached at which the occluded artery begins to open for a very brief period during each cardiac cycle. At this point, the cuff pressure, which is assumed in using this process as being approximately equal to the blood pressure in the brachial artery, will be that of the peak pressure obtained during the cardiac cycle, this pressure being known in the medical arts as the systolic blood pressure.

Detection of the point at which the artery first opens may be made by any suitable listening device such as a stethoscope or microphone applied to the arm over the artery, usually downstream of the inflated cuff. As the artery opens, auscultatory sounds caused by the pulsating blood flow or turbulence in the blood stream below the occlusion are sensed by the listening device, and these sounds are referred to in the medical arts as the well known korotkoff sounds. At the point of first detection, where the decreasing cuff pressure is matched by the maximum blood pressure, medical personnel skilled in the auscultation technique can detect the pulsatile blood flow in the artery and the onset of korotkoff sounds, and thereby determine the systolic blood pressure.

As the pressure in the cuff continues to drop, the korotkoff sounds continue substantially in synchronization with the blood pressure pulses produced during successive cardiac cycles. Eventually a point is reached at which the artery remains open during the entire cardiac cycle and, at this point, the korotkoff sounds cease entirely. The cuff pressure at this point approximates the lowest blood pressure reached during the cardiac cycle, with the heart essentially at rest, and this is known as the diastolic blood pressure.

Hence, it will be apparent that, if values of the decreasing cuff pressure are correlated with the korotkoff sound output of the stethoscope or microphone, the cuff pressure at the time the first korotkoff sound occurs is approximately equal to the systolic blood pressure, while the cuff pressure at the time the last korotkoff sound occurs is approximately equal to the diastolic blood pressure encountered during the measurement process.

It will be apparent from the foregoing that conventional blood pressure measurement procedures using an inflatable cuff and a suitable listening device are prone to a number of significant deficiencies. In this regard, medical personnel making such measurements are required to make rather difficult determinations regarding the presence or absence of korotkoff sounds which may be of relatively low and difficult to detect amplitudes and are often intermixed and easily confused with ambiguous signals generated by artifacts and both internal and external noise. In this regard, noise and artifact signals generally appear to be produced more frequently in sick patients than in healthy patients so that the process is oftentimes more difficult to perform accurately in those instances where the very requirement for a high degree of accuracy is greatest. In addition, the determination of the end points for the onset and cessation of the korotkoff sound pulse train is somewhat subjective and therefore subject to further inaccuracy in the absence of considerable training and much experience on the part of skilled medical personnel.

Since there are relatively few persons really capable of taking accurate blood pressure measurements using conventional manual auscultation techniques, various attempts have been made in the prior art to eliminate the aforedescribed deficiencies by mechanizing the measurement process so that the subjective factors introduced when an untrained person attempts to measure blood pressures can be eliminated and, further, to provide some discrimination against artifacts and noise. However, such automatic systems for measuring blood pressure and, typically, associated heart rate, have generally proven to be overly sensitive to spurious signals generated by artifacts and noise and have proven, therefore, to be in many instances less accurate than medical personnel using tried and true manual procedures. As a consequence, automatic korotkoff sound monitoring systems for determining blood pressure have experienced only limited acceptance by the medical profession.

Hence, those concerned with the development and use of automatic sphygmomanometers in the medical field have long recognized the need for improved sphygmomanometer systems which enable more accurate and reliable blood pressure and heart rate measurements to be made and which obviate the need for a high degree of skill and subjective expertise on the part of medical personnel making such measurements. The present invention fulfills all of these needs.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the present invention provides a new and improved sphygmomanometer system embodying novel methods and apparatus for accurately and reliably detecting, filtering, analyzing, verifying and evaluating a korotkoff sound signal stream in determining systolic and diastolic blood pressures and heart rate for a patient being monitored during a measurement cycle.

Basically, the present invention is directed to an improved electronic method and apparatus for verifying and certifying the genuineness of korotkoff sound signals with a high degree of reliability and separating such true korotkoff sound signals from a variety of artifact and noise signals intermixed with the korotkoff sound signals in the incoming data stream. This is accomplished by waveform analysis first performed upon all of the incoming signal waveforms by means of an analog prescreening subsystem. The analog analysis and filtering process is then continued and further enhanced in a digital processing subsystem imposing additional analysis constraints upon the data to further eliminate any contributions due to noise and artifact signals remaining in the data stream as potentially misleading quasi-korotkoff sound signals and to determine heart rate. The digital processing subsystem then modifies and certifies the resultant data as either reliable or unreliable and applies a plurality of novel manipulations and tests upon the resultant data to determine the most probable values for systolic and diastolic blood pressure levels as indicated by the incoming signal stream detected during the measurement cycle performed upon the patient.

In accordance with the invention, the auscultatory korotkoff sounds are detected by a microphone and the electrical signal output from the microphone is analyzed in a three channel analog prescreening subsystem which filters the incoming data and provides as electrical output a pulse train correctly correlating and marking the locations of korotkoff sound signals in the time and blood pressure domains, with each output pulse being proportional in amplitude to the amplitude of the corresponding korotkoff sound signal represented. The analog prescreening subsystem performs waveform analysis upon all of the incoming signal waveforms, based upon the discovery of certain unique characteristics associated with those waveforms correctly depicting true korotkoff sound signals, in contrast with those waveforms representing a variety of artifact and noise signals. In this connection, it has been discovered that waveform characteristics of the incoming signals, as opposed to frequency characteristics, provide the most reliable means for accurately separating korotkoff sound signals from an electrical signal environment which also includes artifact and noise signals falling within the typical frequency domain associated with true korotkoff sound signals.

It has been discovered, in the development of the present invention, that true korotkoff sound signals produced as incoming data from a microphone transducer always assume one of two general classes of waveform configurations, or hybrid waveforms in between these two classes of waveform configurations which still possess certain key characteristics of one or both general classes, all of which are subject to prescribed analysis and recognition by the system of the present invention. These characteristics include waveform shape, size and direction as measured by polarity, amplitude, slope and timing.

In this regard, it has been determined that diastolic korotkoff sound signals, i.e., those signal waveforms in the korotkoff sound signal stream closer to the lower, diastolic blood pressure end of the korotkoff signal spectrum, always have a precursor in the form of a slowly rising, relatively low frequency region defining a bulge prior to the onset of the oppositely directed korotkoff spike in the waveform. The resultant slowly rising and oppositely directed precursor bulge leading the korotkoff spike will, if the signal waveform depicts a true korotkoff sound, satisfy certain constraints imposed upon the waveform by the analysis performed in the analog prescreening subsystem regarding minimum ampl