Non-invasive system and method for measuring blood pressure variability
11723543 · 2023-08-15
Assignee
Inventors
Cpc classification
A61B5/02416
HUMAN NECESSITIES
A61B5/022
HUMAN NECESSITIES
A61B5/0816
HUMAN NECESSITIES
A61B5/053
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/7278
HUMAN NECESSITIES
International classification
A61B5/0205
HUMAN NECESSITIES
A61B5/00
HUMAN NECESSITIES
A61B5/022
HUMAN NECESSITIES
A61B5/053
HUMAN NECESSITIES
A61B5/08
HUMAN NECESSITIES
Abstract
A non-invasive system and method for measuring blood pressure variability includes a cuff (20) pneumatically connected to a pump (14) to inflate the cuff to be wrapped around a limb (21) of a subject. A pressure sensor (18) is associated with the cuff for measuring cuff pressure (52). A photoplethysmogram sensor (26) attached to a fingertip in the same limb (21) of the subject and placed distal to the cuff for monitoring blood flow and recording a pulse plethysmograph signal. A control unit (12) connected to the pressure sensor (18) and the photoplethysmogram sensor (26) for simultaneously recording the cuff pressure and the plethysmograph signal such that an empirical relationship is derived between the cuff pressure and an amplitude measure of the plethysmograph signal (54) to measure short-term variation in systolic and diastolic blood pressures at a frequency corresponding to respiratory cycle.
Claims
1. A non-invasive blood pressure variability measuring system (10), comprising: a cuff (20) pneumatically connected to a pump (14) to inflate the cuff (20) to be wrapped around a limb (21) of a subject (24); a pressure sensor (18) associated with the cuff (20) for measuring a cuff pressure (52); a photoplethysmogram sensor (26) attached to a fingertip in the same limb (21) of the subject (24) and placed to be distal to the cuff (20) for monitoring blood flow and recording a pulse plethysmograph signal (54); and a control unit (12) connected to the pressure sensor (18) and the photoplethysmogram sensor (26), the system (10) configured to measure a variation in systolic and diastolic blood pressures at a frequency corresponding to that of a respiratory cycle of the subject, wherein the system is configured to either inflate the cuff (20) from a low pressure below the diastolic pressure or deflate the cuff from a pressure higher than the systolic pressure, in steps and hold the pressure at a constant level at every step for a duration of more than one respiratory cycle of the subject, the control unit (12) configured to simultaneously record the cuff pressure (52) and the plethysmograph signal (54) such that an empirical relationship is derived between the cuff pressure (52) and an amplitude measure of the plethysmograph signal (54), and at the same time to assess a distribution of systolic and diastolic pressures, by obtaining variations in the plethysmograph signal during every pressure step, wherein the empirical relationship between the cuff pressure (52) and the amplitude measure of the pulse plethysmograph signal (54) is nonlinear and is determined using a parametric curve fit, and the system is configured to yield a mean value curve and variation curves (85) providing a variation in pressure for each value of the pulse plethysmograph signal (54), wherein the mean value curve and the variation curves provide the distribution of the systolic and diastolic pressures, wherein the empirical relationship between cuff pressure and pulse plethysmograph signal is determined by identifying a peak and trough in the pulse plethysmograph signal (54) and plotting an area under the curve (55) of each pulse plethysmograph signal (54) against the cuff pressure (52), wherein the area under each curve (55) indicates a volume of blood in the finger with each pulse, to yield the range of systolic and diastolic pressures.
2. The system of claim 1, wherein the respiration sensor (22) includes a chest distension sensor belt or a chest electrical impedance respiration sensor and wherein the photoplethysmogram sensor (26) includes a reflective plethysmograph sensor or a transmittive plethysmograph sensor.
3. The system of claim 1, wherein the system is configured to deflate the cuff from a pressure higher than the systolic pressure in steps and hold the pressure at a constant level at each of the steps for the duration of more than the one respiratory cycle.
4. The system of claim 1, wherein the control unit (12) is connected to a pneumatic valve (16) in such a way that the pneumatic valve (16) is connected and placed between the pump (14) and the cuff (20), the control unit (12) configured to control the inflation and deflation of the cuff (20), the system (10) configured to measure the short term variation in the systolic and diastolic blood pressure.
5. The system of claim 1, wherein the cuff pressure (52) is plotted against an amplitude measure of the pulse plethysmograph signal (54) to obtain the range of systolic and diastolic pressures.
6. The system of claim 1, wherein the range of systolic and diastolic blood pressures are determined by tracing two regression lines (62, 64), and the first line (62) to depict a region with no experimentally-induced change in the blood flow and the second line (64) to depict a region where the blood flow starts decreasing due to an external cuff pressure, wherein an intersection (66) of the two lines (62, 64) represents the average diastolic pressure and a zero intercept (68) of the line (64) represents the average systolic pressure, and the intersections of the variation curves with a horizontal line extended from the minimum pulse plethysmograph signal value at zero cuff pressure represents the diastolic pressure range (85) and zero intercepts of the variation curves represents the systolic pressure range.
7. A method (30) for non-invasively measuring blood pressure variability, comprising: inflating a cuff (20) wrapped around a limb (21) of a subject (24) using a pump (14) pneumatically connected to the cuff (20); placing and attaching a photoplethysmogram sensor (26) to a fingertip in the same limb (21) of the subject (24) distal to the cuff (20); simultaneously acquiring and recording a cuff pressure (52) from the cuff (20) and a pulse plethysmograph signal (54) from the photoplethysmogram sensor (26); and including either inflating the cuff (20) from a low blood pressure below the diastolic blood pressure, or deflating the cuff from a pressure higher than the systolic pressure, in steps and holding the pressure at a constant level at each of the steps for a duration more than one respiratory cycle of the subject; deriving an empirical relationship between the cuff pressure (52) and an amplitude measure of the plethysmograph signal (54), and at the same time to assess a distribution of systolic and diastolic pressures by obtaining variations in the plethysmograph signal during every pressure step, and thereby measuring a variation in systolic and diastolic blood pressures at a frequency corresponding to that of a respiratory cycle of the subject, determining the empirical relationship between the cuff pressure (52) and the amplitude measure of the pulse plethysmograph signal (54) using a parametric curve fit in order to yield a mean value curve and variation curves (85) providing variations in systolic and diastolic pressures for each value of the pulse plethysmograph signal (54); identifying a peak and trough in the pulse plethysmograph signal (54) and determining an area under a curve (55) of each pulse plethysmograph signal (54); plotting an area under the curve (55) of each pulse plethysmograph signal (54) against the cuff pressure (52), where the area under each curve (55) indicates a volume of blood in the finger with each pulse; and tracing two regression lines (62, 64) to the mean value curve, the first line (62) to depict a region with no experimentally-induced change in the blood flow and the second line (64) to depict a region where the blood flow starts decreasing due to an external cuff pressure, wherein an intersection (66) of the two lines (62, 64) represents the average diastolic pressure and a zero intercept (68) of the line (64) represents the average systolic pressure, and the intersections of the variation curves with a horizontal line extended from the minimum pulse plethysmograph signal value at zero cuff pressure represents the diastolic pressure range (85) and zero intercepts of the variation curves represents the systolic pressure range.
8. The method of claim 7, further comprising plotting the cuff pressure (52) against a measure of the pulse plethysmograph signal (54) to obtain the variation in systolic and diastolic pressures.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The disclosed embodiments may be better understood by referring to the figures, in which reference numerals refer to identical or functionally-similar elements throughout the separate views, further illustrate the present invention and, together with the detailed description of the invention, serve to explain the principles of the present invention.
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DETAILED DESCRIPTION OF THE INVENTION
(11) The particular values and configurations discussed in these non-limiting examples can be varied and are cited merely to illustrate at least one embodiment and are not intended to limit the scope thereof.
(12) In the following, numerous specific details are set forth to provide a thorough description of various embodiments. Certain embodiments may be practised without these specific details or with some variations in detail. In some instances, certain features are described in less detail so as not to obscure other aspects. The level of detail associated with each of the elements or features should not be construed to qualify the novelty or importance of one feature over the others.
(13) The claimed subject matter has been provided here with reference to one or more features or embodiments. Those skilled in the art will recognize and appreciate that, despite the detailed nature of the exemplary embodiments provided here; changes and modifications may be applied to said embodiments without limiting or departing from the generally intended scope. These and various other adaptations and combinations of the embodiments provided here are within the scope of the disclosed subject matter as defined by the claims and their full set of equivalents. Like numbers refer to like elements throughout.
(14) The present invention relates to an improved cost-effective non-invasive blood pressure monitoring system and method for estimating a range of systolic and diastolic pressures and their short-term variability. The non-invasive blood pressure measuring system uses a controlled pneumatic cuff, a respiration measurement device and a photoplethysmogram to enable estimation of the systolic and diastolic pressures during measurement of the blood pressure variability. The non-invasive blood pressure monitoring system is capable of accurately monitoring the range of blood pressure based on the cuff pressure, respiration cycles and photoplethysmography. The present invention is capable of accurately measuring an average systolic and diastolic pressure, mean pulse pressure and also their variability.
(15)
(16) Note that in
(17) The blood pressure measuring system (10) further includes a pressure sensor (18) associated with the cuff (20) for measuring cuff pressure (52). A photoplethysmogram sensor (26) is attached to a fingertip in the same limb (21) of the subject (24) and placed distal to the cuff (20) for monitoring blood flow and recording a pulse plethysmograph signal (54). In general, photoplethysmogram (PPG) is an optically obtained plethysmogram, a volumetric measurement of an organ. It is a low cost and non-invasive method that makes measurements at the surface of the skin and provides valuable information related to a cardiovascular system. Hereafter, the pulse plethysmograph signal (54) can also be referred as the pulse plethysmograph waveform (54) throughout the description only for the purpose of explanation but not by means of any limitations. The photoplethysmograph sensor (26) can be either reflective or transmittive photoplethysmograph and is placed at a point distal to the cuff (20) to provide a signal related to blood flow. Note that any other method of detecting blood flow distal to the cuff (20) may also be used in lieu of photoplethysmograph sensor (26), depending upon design consideration.
(18) Optionally, a respiration sensor (22) is placed on the chest of the subject (24) for monitoring respiratory movement. The respiration sensor (22) can be a chest distension sensor belt or a chest electrical impedance respiration sensor, based on design consideration. In a preferred embodiment, the cuff (20) is inflated from a low pressure well below diastolic pressure, for example, starting from 0 mmHg or deflated from a higher pressure in steps, such as 2 mmHg or more and held at each pressure step for duration not less than a respiratory cycle. The step size can be chosen to be large or small depending on the desired accuracy. A pressure step of 10 mmHg is suitable for standard measurement. It will be apparent, however, to those of skill in the art that such specifications and parameters can be altered without departing from the scope of the invention.
(19) In a preferred embodiment, the maximum pressure of inflation can be less than the subject's (24) systolic pressure, can be about 80%. This pressure can be even less, if the subject (24) comfort requires it. At each pressure step, the pressure is held constant for a convenient duration involving a few respiratory cycles. The photoplethysmograph signal (54) from one or more complete respiratory cycles is taken for calculations. If the duration is less than or greater than multiples of full respiratory cycles, the measurement of short-term variability of blood pressure can be biased. While the cuff pressure (52) is held at each pressure step, the reading of the pulse photoplethysmogram sensor (26) is recorded.
(20) The system (10) further includes a control unit (12) connected to the pressure sensor (18) and the photoplethysmogram sensor (26) for simultaneously recording the cuff pressure (52) and the plethysmograph signal (54). The control unit (12) derives an empirical relationship between the cuff pressure (52) and an amplitude measure of the plethysmograph signal (54) to measure the variation in the systolic and diastolic blood pressures. The cuff pressure (52) from the pressure sensor (18) and the continuous photoplethysmograph signal (54) from the photoplethysmogram sensor (26) are recorded simultaneously. Using a relationship between the two signals, average systolic, diastolic and pulse pressures and systolic and diastolic pressure variability occurring at about the respiratory frequency can be calculated.
(21) Using the recorded pulse photoplethysmograph signal (54) and the cuff pressure (52), a relation between cuff pressure (52) and photoplethysmographically measured blood flow is determined using a parametric curve fit. In general, curve fitting is the process of constructing a curve, or mathematical function that has the best fit to a series of data points, possibly subject to constraints. Curve fitting can involve either interpolation, where an exact fit to the data is required, or smoothing, in which a “smooth” function is constructed that approximately fits the data.
(22) This curve fitting yields a mean value curve and a variation curve, giving the variation in the pressure for each value of the plethysmographically estimated flow waveform (54). From these curves, the distributions of systolic and diastolic pressures, average pulse pressure and other parameters are obtained. The system (10) is based on obtaining the individualized empirical relationship of the amplitude measure of the photoplethysmogram signal (54) to the cuff pressure (52) and then deriving systolic and diastolic pressure.
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(24) The cuff pressure (52) from the cuff (20) and the pulse plethysmograph signal (54) from the photoplethysmogram sensor (26) are simultaneously acquired and recorded, as indicated at block (40). Referring to
(25) An empirical relationship is derived between the cuff pressure (52) and an amplitude measure of the plethysmograph signal (54) to measure the variation of systolic and diastolic blood pressures at about the respiratory frequency as shown at block (42). Towards this, a peak and trough are identified in the plethysmograph waveform (54) and an area under a curve of each plethysmograph waveform (54) is determined, as indicated at block (44). Referring to
(26) The area under the curve (55) of each pulse plethysmograph waveform (54) is plotted against the cuff pressure (52), where the area under each curve (55) indicates a volume of blood in the finger with each pulse, as shown at block (46).
(27) Regression lines (62) and (64) are traced to depict a region with no experimentally-induced change in the blood flow and a region where the blood flow starts decreasing due to external pressure in the cuff, where an intersection (66) of the two lines (62) and (64) represents the diastolic pressure and a zero intercept (68) of the line (64) represents the systolic pressure, as indicated at block (48). The blood pressure variability is estimated as a variation (eg, standard deviation) from the intercepts (66) and (68) of the regression line (64) after determining the systolic and diastolic pressure, as shown at block (50).
(28) Referring to
(29) Referring to
(30)
(31) The cuff pressure is increased in steps from a low pressure below the diastolic pressure to a maximum that is approximately equal to or higher than systolic pressure. From this model a relation between features of the measured flow waveform and features of arterial pressure waveform is derived as shown below in equation (2).
(32)
(33) Equations (1) and (2) define the blood flow in the finger as seen in a photoplethysmogram sensor (26). Note that equation (1) is a non-linear function. P.sub.d(t) is non-zero only when the arterial pressure exceeds the cuff pressure as given by equation (1). Taking the Fourier transform and rearranging equation (2) the flow is represented in terms of simple algebraic operations:
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(35) This gives the relation between the measured flow and the cuff and arterial pressures in the Fourier or frequency domain. The flow waveform varies with cuff pressure (52) when (a) the cuff pressure (52) is greater than the minimum arterial pressure (diastolic pressure) and (b) the maximum arterial pressure is greater than the cuff pressure (52). These two points are of interest, and are called breakpoint ‘A’ and breakpoint ‘B’ as shown in
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(37) Using Parseval's theorem the quantity on the LHS can be calculated from the time waveform:
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(39) where T is the period of the cardiac cycle waveform. Equation (4) shows that the RMS value of the time waveform from the plethysmogram relate the flow and the cuff pressure (52). Using equations (1, 3, 5) the RMS value of the flow waveform is zero when P.sub.cuff>P.sub.a and maximum when P.sub.cuff<<P.sub.a. For intermediate values of P.sub.cuff, the RMS value of the flow waveform is in-between. The exact relation between the RMS value of flow and the arterial pressure vary with individuals and settings. Therefore, in general, only empirical relations are available. Although the RMS value of flow is used in this discussion based on a simple impedance model of the vasculature, other measures like area under the curve or peak-to-peak amplitude may be used.
(40) The right hand side of equation (4) involves the ratio of the pressure to the impedance. Therefore, the relation between measured flow and pressure is not simply proportional. In a very simple case where the impedance Z(jω) is a simple constant, the pressure can be estimated accurately from the flow using equation (3), by a simple constant of proportionality. But this is not usually tenable. In general, the impedance Z(jω) is a complex function and the relationship between flow and pressure will depend on the wave shape.
(41) In an individual in a short interval of time, the impedance Z(jω) may be assumed to be unchanging, although it is a complex function of frequency. The relationship between pressure and flow in such a situation may be assumed to be unchanging. From equation (1), if P.sub.cuff is adjusted carefully, so that the measure of Q(t) is zero, then P.sub.cuff=P.sub.a, and can be used to determine the value of systolic pressure. This method can also be used to determine the variation in systolic pressure. This can be an exact measure. Using equation (1), if P.sub.cuff is titrated so that the measure of Q(t) is exactly the same as when P.sub.cuff is zero, then the diastolic pressure and its variation can be determined. This however, cannot be an exact measure as small variations of waveform shape and size are inevitable in normal conditions. Plotting the cuff pressure (52) against a measure of the photoplethysmograph waveform, the arterial pressure values can be obtained. With increasing cuff pressure (52), the residual flow as measured by the plethysmogram follows a logistic function (i.e., a quenching function) which can be described algebraically by a function of the form:
(42)
(43) where ‘P’ represents the cuff pressure (52) and the plethysmographic flow (‘Flow’) is dependent on the cuff pressure (52). ‘M’ is the mean value of the flow waveform, IC is steepness of curve.
(44)
(45) From the maximum pulse plethysmograph signal value at each pressure and minimum pulse plethysmograph signal value at each pressure, the range of diastolic can be estimated as the intersection of these curves with a horizontal line extended from the minimum pulse plethysmograph signal value at zero cuff pressure, and the range of systolic pressures can be estimated as the intersection of these curves with the X-axis (pressure axis), as shown in
(46) The choice of curve to fit the data determines the accuracy of estimation of the values. Fine-tuning and validation of the system (10) by comparison against an intra-arterial recording may establish the system (10) as the most preferred for measuring blood pressure, as the system (10) gives more accurate estimates of blood pressure than existing systems, and the system (10) also assesses blood pressure variations at about the respiratory frequency (short-term blood pressure variability). The present system (10) assesses the short-term blood pressure variability non-invasively, and with community level studies, the system (10) will replace the conventional methods which are inaccurate.
(47) It will be appreciated that variations of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Also that various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.