Blood pressure monitoring system

• US 4,216,779 A
• Filed: 05/16/1977
• Issued: 08/12/1980
• Est. Priority Date: 05/16/1977
• Status: Expired due to Term

• Current Assignee: Del Mar Avionics
• Original Assignee: Del Mar Avionics
• Inventors: Cherry, Isaac R., Squires, W. David, Anderson, Donald L.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US05/796,893
• Time in Patent Office: 1,184 Days
• Field of Search: 128/2.05 A, 128/2.05 M, 128/2.05 R, 128/2.06 A, 128/2.06 G, 128/2.05 Q, 128/2.1 A, 128/672, 128/679-683, 128/700, 128/708, 128/710, 346/33 M, 346/33 ME, 360/6, 360/18, 360/27, 364/415, 364/417
• US Class Current: 600/495
• CPC Class Codes: A61B 5/02208 using the Korotkoff method
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: Y10S 128/90 Blood pressure recorder

Abstract

Apparatus is disclosed for long-term ambulatory monitoring of blood pressure by an auscultation method, employing a pressurizable cuff and requiring no intervention by the patient. Heartbeats are sensed by ECG electrodes, and a microphone is used to sense the Korotkow sounds as the pressure in the cuff is varied. The presence or absence of a Korotkow sound within a preset interval following each heartbeat is used in determining when the cuff pressure equals the systolic and diastolic pressures. Those pressures are determined in each cycle of operation and are recorded on a continuously-running portable tape recorder, along with the ECG signals. In each cycle of operation, the initial pressure to which the cuff is inflated is based on the systolic pressure measured in the immediately preceding cycle. The pressure in the inflated cuff is thereafter stepped downward in small discrete decrements triggered by successive heartbeats during the measurement phase of each cycle. After both the systolic and diastolic pressures have been determined, the remaining cuff pressure is vented through the same valve that was used to produce the stepwise pressure reduction. After a number of cycles of operation, the magnetic tape is removed from the portable recorder and inserted into an analyzer for high-speed playback and automated plotting of the heart rate and accompanying blood pressure readings on a common chart.

Claims

1. A portable apparatus for long-term ambulatory monitoring and recording of a patient'"'"'s systolic and diastolic blood pressure by the auscultatory method, requiring no intervention by the patient and comprising in combination:

an inflatable cuff affixable to the patient;

a source of fluid under pressure for inflating said cuff to an initial inflation pressure greater than the patient'"'"'s systolic blood pressure during an initial phase of each cycle of operation in response to an applied inflation signal, and thereafter for remaining sealed off from the cuff during the remainder of each cycle of operation;

a pressure transducer for sensing the pressure of the fluid in said cuff and for generating a pressure signal representative of the pressure;

a valve connected to the cuff and having a normal first state in which it vents said cuff to a region of lower pressure, and alterable by applied control signals to a second state in which it connects said cuff to said source of fluid;

a valve control circuit connected to said valve and generating the control signals applied to said valve to selectively control its state in response to a stored initial inflation pressure signal stored in said valve control circuit and to the pressure signal generated by said pressure transducer to cause said cuff to be inflated to the stored initial inflation pressure during the initial phase of each cycle of operation, the initial inflation pressure signal for the first cycle of operation being preset and the initial inflation pressure signal for each subsequent cycle of operation being determined by said valve control circuit from the greatest pressure measured by said portable apparatus in the immediately preceding cycle of operation and retained in storage by said valve control circuit, said valve control circuit responding to stepping signals generated and applied after the initial inflation phase of each cycle of operation to initiate the control signals applied to said valve to selectively and intermittently vent said cuff to a region of lower pressure momentarily producing an abrupt decrease of the cuff pressure by a constant predetermined decrement upon the occurrence of each of said stepping signals until the cuff pressure has been reduced through a series of constant pressure decrements from the initial inflation pressure greater than the patient'"'"'s systolic blood pressure to a final cuff pressure less than the patient'"'"'s diastolic blood pressure;

a K-sound transducer positioned on the patient in relation to said inflatable cuff for sensing the patient'"'"'s K-sounds during the intervals when the cuff pressure is constant between successive pressure decrements and for generating a K-sound signal representative of the K-sounds;

a discrimination circuit responsive to the K-sound signal for identifying the first and last of the K-sounds sensed by said K-sound transducer in each cycle of operation and responsive to the pressure signal for producing an output data signal representing the systolic and diastolic pressures sensed by said pressure transducer at the time of occurrence within each cycle of operation of the first and last K-sounds respectively, said discrimination circuit connected to said valve control circuit and producing the stepping signals and applying the stepping signals to said valve control circuit.

2. The apparatus of claim 1, further comprising a pair of ECG electrodes for sensing the patient'"'"'s electrocardial potentials and for providing an ECG signal representative thereof, and wherein said discrimination circuit is responsive to the ECG signal to generate the stepping signal applied to said valve control circuit.

3. The apparatus of claim 2 wherein said discrimination circuit includes means for determining when the patient'"'"'s R-waves can be recognized in said ECG signal, and when the R-waves can be recognized said discrimination circuit generates and applies to said valve control circuit a stepping signal in timed relation to each R-wave, whereby the cuff pressure is reduced in a stepwise manner, the successive decrements of pressure being paced by successive R-waves.

4. The apparatus of claim 3 wherein said means determines when the patient'"'"'s R-waves can be recognized in said ECG signal, and when the R-waves cannot be recognized said discrimination circuit generates and applies to said valve control circuit stepping signals having a constant repetition frequency, whereby the cuff pressure is reduced in a stepwise manner, the successive decrements of pressure being equally spaced in time.

5. The apparatus of claim 2 wherein said discrimination circuit including means for determining when the patient'"'"'s R-waves can be recognized in said ECG signal, and if the R-waves cannot be recognized said discrimination circuit generates and applies to said valve control circuit stepping signals having a constant repetition frequency, whereby the cuff pressure is reduced in a stepwise manner, the successive decrements of pressure being equally spaced in time.

6. The apparatus of claim 1 wherein said discrimination circuit, upon detecting the occurrence of a K-sound within a limited defined time interval after the end of the initial inflation phase of a cycle, generates a signal for application to said valve control circuit, said valve control circuit including means responsive to said signal for terminating the measurement cycle for augmenting the stored initial inflation pressure signal by a predetermined increment and for generating an inflation signal to increase the cuff pressure to the pressure represented by the augmented initial inflation pressure signal.

7. In an apparatus for monitoring a patient'"'"'s blood pressure by the auscultatory method, of the type including an inflatable cuff for affixation to the patient, a source of fluid under pressure for inflating the cuff to an initial inflation pressure during an initial phase of each cycle of operation in response to an applied inflation signal, and thereafter for remaining sealed off from the cuff during the remainder of each cycle of operation, further including a pressure transducer for sensing the pressure of the fluid in the cuff and for generating a pressure signal representative of the pressure, further including a valve connected to the cuff and having a normal first state in which it vents the cuff to a region of lower pressure, and alterable by applied control signals to a second state in which it connects the cuff to the source of fluid, further including a K-sound transducer positioned on the patient in relation to the inflatable cuff for sensing the patient'"'"'s K-sounds and for generating a K-sound signal representative of the K-sounds, further including a pair of ECG electrodes for sensing the patient'"'"'s electrocardial potentials and for providing an ECG signal representative thereof, and further including a discrimination circuit responsive to the K-sound signal and to the ECG signal for identifying the first and last of the K-sounds sensed by the K-sound transducer in each cycle of operation and responsive to the pressure signal for producing an output data signal representing the systolic and diastolic pressures sensed by the pressure transducer at the time of occurrence within each cycle of operation of the first and last K-sounds respectively, the discrimination circuit employing the ECG signal to generate the stepping signal applied to the valve control circuit, the improvement comprising:

means within said discrimination circuit for encoding said output data signal into a serial digital pulse-width modulated form; and

,

a portable magnetic tape recorder connected to said discrimination circuit for recording the encoded output data signal, and having means for combining the ECG signal and the encoded output data signal into a combined signal and for recording the combined signal on a single track in a magnetic tape to preserve the time relationship between the ECG signal and the blood pressure information represented by the output data signal.

8. The improvement of claim 7 further comprising:

a magnetic tape playback unit for playing back said magnetic tape at a faster speed than that at which it was recorded, to produce a playback electrical signal representative of said combined signal;

a data decoder connected to said magnetic tape playback unit and responsive to said combined signal to separate said ECG signal from said output data signal; and

,

a heart rate trend computer connected to said data decoder and responsive to said ECG signal to produce a heart rate signal representative of the patient'"'"'s heart rate.

9. The improvement of claim 8 further comprising:

plotter means responsive to said output data signal produced by said data decoder and to said heart rate signal produced by said heart rate trend computer to produce on a common chart representations of both said output data signal and said heart rate signal.

10. The improvement of claim 8 further comprising:

printer means responsive to said output data signal produced by said data decoder for printing numerical symbols representing measured values of the patient'"'"'s blood pressure.

11. The improvement of claim 7 wherein said portable magnetic tape recorder also simultaneously records on the common magnetic tape an event marker signal initiated by the patient and generated by said portable magnetic tape recorder.

12. The improvement of claim 7 wherein said portable magnetic tape recorder generates an event marker signal under control of the patient and wherein said means for combining combines the event marker signal with the ECG signal and the output data signal, and wherein the combined signal is recorded on a single track on said magnetic tape.

13. In an apparatus for monitoring a patient'"'"'s blood pressure by the auscultatory method, of the type including an inflatable cuff for affixation to the patient, a source of fluid under pressure for inflating the cuff to an initial inflation pressure during an initial phase of each cycle of operation in response to an applied inflation signal, and thereafter for remaining sealed off from the cuff during the remainder of each cycle of operation, further including a pressure transducer for sensing the pressure of the fluid in the cuff and for generating a pressure signal representative of the pressure, further including a valve connected to the cuff and having a normal first state in which it vents the cuff to a region of lower pressure, and alterable by applied control signals to a second state in which it connects the cuff to the source of fluid, further including a K-sound transducer positioned on the patient in relation to the inflatable cuff for sensing the patient'"'"'s K-sounds and for generating a K-sound signal representative of the K-sounds, further including a pair of ECG electrodes for sensing the patient'"'"'s electrocardial potentials and for providing an ECG signal representative thereof, and further including a discrimination circuit responsive to the K-sound signal and to the ECG signal for identifying the first and last of the K-sounds sensed by the K-sound transducer in each cycle of operation and responsive to the pressure signal for producing an output data signal representing the systolic and diastolic pressures sensed by the pressure transducer at the time of occurrence within each cycle of operation of the first and last K-sounds respectively, the discrimination circuit employing the ECG signal to generate the stepping signal applied to the valve control circuit, the improvement comprising in combination:

circuit means, within said discrimination circuit, which upon detecting the occurrence of a K-sound within a limited defined time interval after the end of the initial inflation phase of a cycle, generates a signal for application to the valve control circuit, said valve control circuit including means responsive to said signal for terminating the measurement cycle, for augmenting the initial inflation pressure and for generating an inflation signal to increase the cuff pressure to an augmented initial inflation pressure.

14. The improvement of claim 13 wherein said circuit means, upon failing to detect a K-sound within a limited defined time interval after the end of the initial inflation phase of a cycle, generates a signal for application to the valve control circuit, said valve control circuit including means responsive to said signal for decreasing the initial inflation pressure for the next cycle of operation.

15. A method for repeatedly measuring a patient'"'"'s systolic blood pressure by an auscultatory method, wherein in each measurement cycle an inflatable cuff fixed to the patient is inflated to an initial inflation pressure and thereafter in each measurement cycle the cuff pressure is gradually reduced so that the K-sounds can be heard, the cuff pressure at the onset of the K-sounds being indicative of the systolic blood pressure and the cuff pressure at the cessation of the K-sounds being indicative of the diastolic blood pressure, said method comprising the steps of:

(a) inflating the cuff, at the beginning of the first cycle to a preset initial inflation pressure;

(b) determining whether or not K-sounds are heard within a limited defined time interval after the cuff has been inflated and proceeding to step (c) if K-sounds were heard within the interval and to step d) if K-sounds were not heard within the interval;

(c) increasing the cuff pressure to a value greater than the preset initial inflation pressure and repeating step (b);

(d) measuring and storing the systolic and diastolic blood pressures;

(e) incrementing the stored systolic blood pressure measurement by a predetermined increment to obtain the initial inflation pressure for the next measurement cycle;

(f) inflating the cuff at the beginning of the next measurement cycle to the initial inflation pressure determined in step (e) and repeating step (b).

16. The method of claim 15 wherein step (d) further comprises the step of:

producing an abrupt decrease of the cuff pressure by a constant predetermined decrement following each of the patient'"'"'s heartbeats, whereby over an extended time interval the cuff pressure decreases through a series of steps of constant magnitude paced by the patient'"'"'s heartbeats from an initial pressure greater than the patient'"'"'s systolic blood pressure to a pressure less than the patient'"'"'s diastolic blood pressure.

17. The method of claim 16 further comprising the preparatory step of:

sensing the patient'"'"'s heartbeats from an ECG signal produced by the patient.

18. The method of claim 17 further comprising the step of:

recording the ECG signal in analog form and the blood pressure signals on a single track of a magnetic tape by means of a portable tape recorder affixed to the patient, the intermittent blood pressure signals being interspersed between successive segments of the ECG signal to preserve the time relationship between the signals.

19. The method of claim 18 further comprising the subsequent steps of:

playing back the magnetic tape at a faster rate than that at which it was recorded, to produce a combined signal representing both the ECG signal and the blood pressure signals;

separating the combined signal into components separately representing the ECG signal and the blood pressure signals.

20. The method of claim 19 further comprising the subsequent step of:

producing a heart rate signal from the ECG signal.

21. The method of claim 20 further comprising the subsequent step of:

plotting both the blood pressure signals and the heart rate signal versus time on the same chart.

22. The method of claim 20 further comprising the subsequent steps of:

plotting the heart rate signal versus time on a chart and printing numerical symbols on the chart representing the blood pressure measurements.

23. A portable apparatus for long-term ambulatory monitoring and recording of a patient'"'"'s systolic and diastolic blood pressure by the auscultatory method, requiring no intervention by the patient, and apparatus for playing back and analyzing the recorded blood pressure data, comprising in combination:

an inflatable cuff affixable to the patient;

a source of fluid under pressure for inflating said cuff to an initial inflation pressure greater than the patient'"'"'s systolic blood pressure during an initial phase of each cycle of operation in response to an applied inflation signal, and thereafter for remaining sealed off from the cuff during the remainder of each cycle of operation;

a pressure transducer for sensing the pressure of the fluid in said cuff and for generating a pressure signal representative of the pressure;

a valve connected to the cuff and having a normal first state in which it vents said cuff to a region of lower pressure, and alterable by applied control signals to a second state in which it connects said cuff to said source of fluid;

a valve control circuit connected to said valve and generating the control signals applied to said valve to selectively control its state in response to a stored initial inflation pressure signal stored in said valve control circuit and to the pressure signal generated by said pressure transducer to cause said cuff to be inflated to the stored initial inflation pressure during the initial phase of each cycle of operation, the initial inflation pressure signal for the first cycle of operation being preset and the initial inflation pressure signal for each subsequent cycle of operation being determined by said valve control circuit from the greatest pressure measured by said portable apparatus in the immediately preceding cycle of operation and retained in storage by said valve control circuit, said valve control circuit responding to stepping signals generated and applied after the initial pressure inflation phase of each cycle of operation to initiate the control signals applied to said valve to selectively and intermittently vent said cuff to a region of lower pressure momentarily producing an abrupt decrease of the cuff pressure by a constant predetermined decrement upon the occurrence of each of said stepping signals until the cuff pressure has been reduced through a series of constant pressure decrements from the initial inflation pressure greater than the patient'"'"'s systolic blood pressure to a final cuff pressure less than the patient'"'"'s diastolic blood pressure;

a K-sound transducer positioned on the patient in relation to said inflatable cuff for sensing the patient'"'"'s K-sounds during the intervals when the cuff pressure is constant between successive pressure decrements and for generating a K-sound signal representative of the K-sounds;

an ECG electrode for sensing the patient'"'"'s electrocardial potentials and for providing an ECG signal representative thereof;

a discrimination circuit responsive to the K-sound signal for identifying the first and last of the K-sounds sensed by said K-sound transducer in each cycle of operation and responsive to the pressure signal for producing an output data signal representing the systolic and diastolic pressures sensed by said pressure transducer at the time of occurrence within each cycle of operation of the first and last K-sounds respectively, said discrimination circuit connected to said valve control circuit and producing the stepping signals and applying the stepping signals to said valve control circuit;

said discrimination circuit responsive to the ECG signal to generate the stepping signal applied to said valve control circuit;

said discrimination circuit further comprising means for encoding said output data signal into a serial digital pulse-width modulated form; and

,

a portable magnetic tape recorder connected to said discrimination circuit for recording the encoded output data signal, and having means for combining the ECG signal and the encoded output data signal into a combined signal and for recording the combined signal on a single track in a magnetic tape to preserve the time relationship between the ECG signal and the blood pressure information represented by the output data signal.

24. The apparatus of claim 23 wherein said means for combining further comprises multiplexer means.

25. The apparatus of claim 23 further comprising:

a magnetic tape playback unit for playing back said magnetic tape at a faster speed than that at which it was recorded, to produce a playback electrical signal representative of said combined signal;

a data decoder connected to said magnetic tape playback unit and responsive to said combined signal to separate said ECG signal from said output data signal; and

,

a heart rate trend computer connected to said data decoder and responsive to said ECG signal to produce a heart rate signal representative of the patient'"'"'s heart rate.

26. The apparatus of claim 25 further comprising;

plotter means responsive to said output data signal produced by said data decoder and to said heart rate signal produced by said heart rate trend computer to produce on a common chart representations of both said output data signal and said heart rate signal.

27. The apparatus of claim 23 wherein an event marker signal initiated by the patient and generated by said portable magnetic tape recorder is also recorded on said magnetic tape.

28. The apparatus of claim 23 wherein said portable magnetic tape recorder generates an even marker signal under control of the patient and wherein said means for combining combines the event marker signal with the ECG signal and the output data signal and wherein said combined signal recorded on a single track on said magnetic tape includes an event marker signal.

29. The apparatus of claim 23 wherein said discrimination circuit includes means for determining when the patient'"'"'s R-waves can be recognized in said ECG signal, and when the R-waves can be recognized said discrimination circuit generates and applies to said valve control circuit a stepping signal in timed relation to each R-wave, whereby the cuff pressure is reduced in a stepwise manner, the successive decrements of pressure being paced by successive R-waves.

30. The apparatus of claim 29 wherein said means determines when the patient'"'"'s R-waves can be recognized in said ECG signal, and when the R-waves cannot be recognized said discrimination circuit generates and applies to said valve control circuit stepping signals having a constant repetition frequency, whereby the cuff pressure is reduced in a stepwise manner, the successive decrements of pressure being equally spaced in time.

31. The apparatus of claim 23 wherein said discrimination circuit including means for determining when the patient'"'"'s R-waves can be recognized in said ECG signal, and if the R-waves cannot be recognized said discrimination circuit generates and applies to said valve control circuit stepping signals having a constant repetition frequency, whereby the cuff pressure is reduced in a stepwise manner, the successive decrements of pressure being equally spaced in time.

32. The apparatus of claim 23 wherein said discrimination circuit, upon detecting the occurrence of a K-sound within a limited defined time interval after the end of the initial inflation phase of a cycle, generates a signal for application to said valve control circuit, said valve control circuit including means responsive to said signal for terminating the measurement cycle, for augmenting the stored initial inflation pressure signal by a predetermined increment and for generating an inflation signal to increase the cuff pressure to the pressure represented by the augmented initial inflation pressure signal.