The present invention relates to both a method and an apparatus for noninvasive arterial blood pressure measurement and individualized rectifying technology using the method for continuous blood pressure measurement.
Noninvasive blood pressure (BP) measurement is the technology to measure the BP indirectly by the parameter detection of an arterial vessel wall's beat or arterial volume. There are two types of noninvasive BP measurement: intermissive measurement and continuous measurement. Intermissive measurement can get the value of BP at specific time points, but due to the consistent change of BP on the arterial vessel wall at every heart beat and every time point, the systolic pressure and the diastolic pressure may not represent a meaningful value for a given subject, and these two values relate to different heart beats. Continuous measurement technology, which measures the BP without intermission, can provide the beat-to-beat BP or a continuous arterial BP wave. It is very important to realize noninvasive continuous BP measurement. But, until now, there is not an ideal measurement method that can achieve that aim.
BP measurement according to the pulse wave transit velocity (PWTV) is a type of noninvasive continuous BP measurement method. In 1922, Bazzett discovered that the PWTV or pulse wave transit time (PWTT) relates to arterial blood pressure, and additionally relates to arterial volume and the arterial vessel wall's flexibility. In 1957, Lansdown pointed that PWTT and arterial BP present a linear relationship to some extent and that this relationship is stable for a given subject in a period of time. Moreover, the coefficients that describe the linear relationship between PWTT and BP vary widely for different subjects with different arterial vessel tissue structures. But in past studies, the BP according to PWTT of different subjects was generally evaluated through the same coefficients, so the results can be distorted by errors.
An equation describing the relationship between beat-to-beat BP and PWTT for a given subject can be deduced based on the linear relationship between them:
BP=a+b×PWTT (A)
wherein, BP is arterial blood pressure, PWTT is pulse wave transit time, a and b are regressing coefficients to be estimated and which vary in different subjects, but for which in a given subject and over a short period, they are stable. Previous analysis shows that to evaluate arterial BP, the coefficient of a and b for a given subject must be obtained firstly, and after that, continuous arterial BP for a given subject can be computed by the continuous detection of PWTT (or PWTV). The coefficient a and b need to be rectified by means of individualized regressing technology, so that the value of continuous arterial BP computed by the regressing equation (A) can fit individual conditions well during the continuous detection of a pulse wave.
In principle, evaluating two pending parameters requires two groups of independent experimental data. PWTT and mean arterial pressure in the quiet condition for a given subject can be obtained, so coefficient a, i.e., the intercept, is easy to determine. Coefficient b=ΔBP/ΔPWTT, i.e., the slope, is always estimated by altering BP to get two groups of data. In order to change BP, exercise or drugs were often involved in the experiment, which can change the artery character and violate the premise that in a short period the linear relationship in equation (A) is consistent.
Yu Mengsun also believed that when body posture changed (for example, between supine and when elevating a leg), PWTT in the elevated leg would change. It is because the change of body posture alters the pressure in some vessels and then makes PWTV different from that of the normal state. If experimental data in a normal status and a posture changing status can be obtained, the coefficients a and b can be estimated from these data. This method can rectify parameters more accurately, but multi-group information relating to the beat-to-beat BP cannot be continuously gotten with the body posture changed.
The purpose of the present invention is to offer a method and an apparatus that can measure the beat-to-beat arterial blood pressure from the information of arterial blood pressure. The invention also relates to an individualized rectifying technology which makes the blood pressure estimated by using continuous pulse wave measurement correspond to the individual reality.
To resolve the above problems, the invention uses a method to measure the arterial blood pressure:
(1) Wrapping the cuff around the trunk or limb of the subject; getting a series of different values of cuff pressure P and the corresponding Korotkoff's sound delay times TK; getting a functional relation of TK=H(P) between Korotkoff's sound delay time and cuff pressure.
(2) Calculating Korotkoff's sound delay time (TKm) under the corresponding cuff pressure (Pm); according to the fact that the change of delay time caused by change of cuff pressure is approximately equal in magnitude and inverse in direction compared with the change caused by blood pressure and using the equation relation of TK=H(P) between Korotkoff's sound delay time TK and cuff pressure P, we can estimate the change of blood pressure corresponding to the detected Korotkoff's sound delay time.
The Korotkoff's sound delay time mentioned above is the time that the Korotkoff's sound arrived from the fixed reference point to the corresponding cycle of a heartbeat. Said fixed reference point can be the ECGR wave peak (
The equipment to implement the above method comprises: the cuff, the inflating unit and deflating unit for the cuff the cuff pressure sensor, the Korotkoff's sound sensor, and the ECG electrode. The output signal ports of the cuff pressure sensor and Korotkoff's sound sensor are connected to the microprocessor through the signal conditioning circuit. The ECG electrode is connected to the microprocessor via an ECG circuit, and the microprocessor has a printing output and/or data display equipment.
The individualized rectifying technology according to said method is:
Constructing a regress equation between a pulse wave transit time (PWTT) and beat-to-beat arterial blood pressure (BP),
BP=a+b×PWTT (A)
In the equation, BP is the arterial blood pressure, PWTT is the pulse wave transit time corresponding to the BP, and the parameters a and b are the regress coefficients. After individualized rectification of the parameters a and b, based on the continuous measurement of pulse wave transit time and using the above equation, we can estimate the continuous change of the individual blood pressure for a given subject, characterized in that the individualized rectifying method for b is:
(1) Wrapping the cuff around the trunk or limb of the given subject, getting a series of different values of cuff pressure P and the corresponding Korotkoff's sound delay times TK; then we can get the function relation of TK=H(P) between Korotkoff's sound delay time and cuff pressure.
(2) Calculating Korotkoff's sound delay time under the corresponding cuff pressure Pm, using the said function relation of TK=H(P) between Korotkoff's sound delay time and cuff pressure, we can estimate the change value of blood pressure corresponding to the Korotkoff's sound delay time.
(3) Recording the pulse wave transit times corresponding to the Korotkoff's sound delay time in step 2.
(4) Based on the data measured in step 2 and 3, calculating the proportional coefficient between the change of mean arterial pressure ΔBP and the change of pulse wave transit time ΔPWTT, then we can obtain individualized rectified parameter b.
In step 2 of the individualized rectifying method, the mean arterial pressure Pm is preferred for said corresponding cuff pressure.
A further method of individualized rectifying technology is: during the measurement of the Korotkoff's sound delay time based on the corresponding cuff pressure in step 2, and by directing the subject's own behavior that can alter the blood pressure of the subject but which does not change the characteristic of the vascular wall, we can enhance the range of blood pressure change between different measurement points.
Further, the behavior that can alter the blood pressure of the subject is a deep breath.
The above-mentioned equation constructed for the subject is a regress equation between the PWTT and beat-to-beat arterial BP. The method of the present invention is the same with the equation between PWTV (pulse wave transit velocity) and beat-to-beat arterial BP, or other linear regress equations that have different performance details but have the same essence.
The present invention is designed based on the study about the relationship between Korotkoff's sound delay time TK, the cuff pressure P, and arterial blood pressure BP. The following is the introduction of the invention's principle.
When measuring blood pressure by the conventional stethoscope method (also called Korotkoff's sound method), we firstly inflate the cuff until the cuff pressure exceeds systolic blood pressure, when the artery is impacted and shut off so that there is no blood flow in the artery. Then while deflating the cuff slowly, referring to
To analyze the principle of the phenomenon, we find that the pressure change inside the artery is a gradual process rather than a sudden or abrupt rising. So with the decreasing of the pressure inside the cuff, within each heartbeat cycle, the earlier the artery opens, the earlier Korotkoff's sound appears. And also according to the fixed reference point (such as the R wave in an electrocardiogram or the rising point of the pulse wave inside the cuff or some other fixed reference point) in each corresponding cycle, Korotkoff's sound delay times are shorter and shorter.
We can draw a conclusion that Korotkoff's sound delay times decrease gradually with the dropping of the cuff pressure, so the functional relationship which is formed from a series of Korotkoff's sound delay times TK and their corresponding cuff pressure P (referring to
Additionally,
The above-mentioned functional relationship of TK=H(P) is obtained when cuff pressure is descending while BP is stable; at the same time, we observe that if cuff pressure is at a constant pressure between systolic blood pressure and diastolic blood pressure, pressure change inside the artery will result in the change of artery transmural pressure, and consequently Korotkoff's sound delay time will change. It can be considered that the change of Korotkoff's sound delay time induced by cuff pressure changes when blood pressure is stable is the same in size and inverse in direction of that induced by blood pressure change when cuff pressure is stable.
According to the above-mentioned rule, the present invention can estimate the blood pressure change of each heartbeat cycle corresponding to each Korotkoff's sound by detecting the Korotkoff's sound delay time under a specific cuff pressure. The method can also evaluate the blood pressure change of each beat.
The above-mentioned individualized rectifying technology of a continuous arterial blood pressure monitoring regress equation is based on the finding that the corresponding change of arterial blood pressure can be estimated by the Korotkoff's sound delay time. The following is the principle of this technology:
Supposing the regress equation between pulse wave transit time PWTT and beat-to-beat arterial blood pressure BP is:
BP=a+b×PWTT (A)
Before using PWTT to measure BP, the parameters a and b for a given subject must be calculated first. With some technologies, the subject's mean arterial blood pressure BP0 and corresponding pulse wave transit time PWTT0 can be measured, so the parameter a will be easy to get if the parameter b has been gotten. With two groups of blood pressure values and PWTT values at two different blood pressure levels, there must be two factors to obtain the parameter b, that is:
1. To change the value of the BP; and
2. To detect the change of the BP.
In fact, a human's BP is changing at any moment. But the instantaneous change of BP can't be measured non-invasively with the known technology, so the parameters can't be rectified by spontaneous BP change. The present invention can estimate the change of BP per beat based on the Korotkoff's sound delay time, and measure individualized rectifying parameters by using instantaneous changes of BP.
Otherwise, the change of BP and the change of the corresponding PWTT are so small in a quiet state that the error of calculation will inescapably increase. In order to increase the Signal-to-Noise Ratio (SNR) and get the bigger instantaneous change of BP, the prior project of this invention also tries to control breath or some other actions to alter the subject's BP.
The work process of the present invention's apparatus is: the cuff pressure P can be gradually increased or decreased through an inflation unit. In this process, a Korotkoff's sound sensor measures the arrival time of the sound and sends it to the CPU. At the same time, a heart beat signal is also sent to the CPU through electrocardiogram electrodes and an electrocardiogram detecting circuit. Thereby the value of time interval TK that is from the fixed reference point of every heart beat cycle to the Korotkoff's start-point in the same cycle can be gotten, and the function of TK=H(P) in the present invention can be obtained. Keeping the cuff pressure at a fixed value through a cuff pressure controller, measuring Korotkoff's sound delay time TKm at the cuff pressure and using the function of TK=H(P) to get the blood pressure change in the current heart cycle compared to the initial measurement (when the function of TK=H(P) was obtained).
The method and apparatus in the present invention can provide beat-to-beat arterial blood pressure estimation, and create a new way for individualized rectifying technology of a continuous arterial blood pressure monitoring regress equation. This technology can use an instantaneous change of BP to get individualized rectifying parameters, and it can increase the possibility of technical realization for long-time noninvasive continuous blood pressure monitoring, with many merits such as safety, availability, less error and briefness.
The present invention applies deep breath to enhance the range of blood pressure changes of a subject in individualized rectifying method, which can improve the accuracy of rectification and reduce the errors and which is safe and reliable for the subject.
The following is about how to measure the arterial BP value of a certain heartbeat:
1. Wrapping the cuff around a subject's upper arm, obtaining a mean blood pressure value BP0 by an oscillometric or an auscultatory method, and measuring the corresponding pulse wave transit time value PWTT0 simultaneously.
2. Recording a series of Korotkoff's sound delay time values TK and the corresponding cuff pressure values P during deflation of the cuff, then constructing the function of TK=H(P) between the Korotkoff's sound delay time and the cuff pressure value when the subject's mean blood pressure is at the level of BP0. Obtaining the curve (
Based on these said individualized functions, the following data can be measured and calculated.
3. Measuring Korotkoff's sound delay time value TKm when the cuff pressure is at a certain known value Pm that is between systolic blood pressure SBP and diastolic blood pressure DBP. Based on the function of TK=H(P), obtaining Korotkoff's sound delay time TKm0 when the cuff pressure value is equal to Pm, and calculating the difference ΔTKm between TKm and TKm0.
4. Calculating the g(Pm) value when the cuff pressure value is equal to Pm, according to the said function of g(P), in which the dTK/dP of each point changes with the cuff pressure value P.
5. Based on the equation: g(Pm)=ΔTKm/ΔBPm, obtaining the BP change value ΔBPm corresponding to the Korotkoff's sound delay time value TKm.
The blood pressure value of this beat is equal to the summation of the BP change ΔBPm and the mean blood pressure value BP0 that is used to establish the function of TK=H(P).
The following is the principle of said method: If the BP level when the TKm is measured is equal to the BP level BP0 when the function of TK=H(P) was established, the obtained Korotkoff's sound delay time value TKm should be equal to Korotkoff's sound delay time value TKm0 which is calculated from the fitted curve TK=H(P) while the corresponding pressure is equal to Pm. Otherwise, it means that the BP has changed. If the blood pressure increases, the delay time value TKm is shorter; and if the blood pressure decreases, the delay time value TKm is longer (shown as
This is about how to measure beat-to-beat arterial blood pressure.
1. Obtaining a series of Korotkoff's sound delay time values TK and the corresponding cuff pressure values P during deflation of the cuff, and constructing the function of TK=H(P) as shown in embodiment 1. After two curve fittings about these discrete data, establishing the curve of TK=H(P) that Korotkoff's sound delay time value TK changed with cuff pressure value P.
2. Calculating the difference value of said fitted curve TK=H(P), and obtaining a new function of g(P) in which the Korotkoff's sound delay time changes with one unit pressure (1 mm Hg), as shown in
3. Maintaining the cuff pressure at the constant level P0 that is approximately equal to a mean blood pressure which is between the systolic blood pressure SBP and the diastolic blood pressure DBP, and then getting a series of beat-to-beat Korotkoff's sound delay times T(i) (shown as
4. Calculating the difference T′(i) of the said T(i) in the condition of the said approximate constant puff pressure P0 (shown as 7-3). The relationship is shown as the following equation.
T′(i)=T(i+1)−T(i) . . . (i=1,2,3 . . . )
5. Each T′(i) is corresponding to a known cuff pressure Pi, and each pressure Pi is corresponding to a unique datum, g(Pi)=dTK/dP. Therefore, calculating the dynamic BP change value ΔBP(i) of each beat by using the coefficient g(Pi) corresponding to the T′(i) (shown as
ΔBP(i)=T′(i)/g(Pi)
Adding up ΔBP(i) of each beat, and obtaining the beat-to-beat continuous BP change value BP(n) (shown as
wherein n=1 . . . m−1, m is the number of heartbeat cycles when the cuff pressure keeps approximate stable, and BP is the dynamic blood pressure. According to the above equation, the beat-to-beat BP change can be calculated.
The calculated arterial blood pressure change is more close to the actual status when the cuff pressure is at the level of mean blood pressure value or close to it.
This is an embodiment to implement individualized rectification by using the data of arterial blood pressure measurement method of this invention.
The regress equation of PWTT and beat-to-beat arterial blood pressure BP is:
BP=a+b×PWTT (A)
Wherein, BP is blood pressure, PWTT is pulse wave transmit time, and a and b are pending regress coefficients.
The method of individualized rectification of coefficient a and b is as the following:
(1) Putting the cuff and Korotkoff's sound sensor in the distal cuff on one of the upper arms of the subject, measuring blood pressure by an auscultatory method and getting the systolic blood pressure and diastolic blood pressure, calculating the mean arterial pressure BP0 by empirical formula (which can also be accurately measured by oscillometric method), and recording the synchronous pulse wave transmit time (PWTT0).
(2) Getting a series of pulse wave transmit times and the corresponding cuff pressures in the whole deflating process in the same way as in the embodiment 1, constructing the function of TK(P); getting the curve of Korotkoff's sound delay time TK changes with cuff pressure P (
(3) Keeping the cuff pressure at a constant pressure between systolic blood pressure and diastolic blood pressure, getting a series of beat-to-beat Korotkoff's sound delay times and the corresponding pulse wave transmit times. In the measurement process, making the subject breathe deeply several times (e.g., 3 times), getting two groups of data arbitrarily, calculating the difference of Korotkoff's sound delay times at different times ΔT. Based on the series of functions of g(P) which is shown in item 2, calculating the value of g at the corresponding cuff pressure, using AT to estimate the change of arterial blood pressure ΔBP1; calculating the change of the synchronous pulse wave transmit time ΔPWTT1.
That is, getting the regressive coefficient b1=ΔBP1/ΔPWTT1.
In the same way, getting the b2, b3 . . . separately based on several groups of data.
Calculating the average or median of the series b1, b2, b3 . . . , thus the regressive coefficient can represent the actual individual parameters.
In addition, you can also directly calculate the regressive coefficient by using the first BP signal and the second PWTT signal, and the regressive coefficient is the coefficient b of the blood pressure function.
In this embodiment, the controlling ports of inflating and deflating units connect to a CPU, which controls the inflating and deflating. The analog signals output from the cuff pressure sensor are amplified, low-pass and band-pass filtered, and converted to digital signals by an A/D converter and input to the CPU; the output signals of the Korotkoff's sound sensor are amplified, filtered, converted to digital signals by an A/D converter and input to the CPU; electrocardiogram circuits connect electrodes and the CPU.
Number | Date | Country | Kind |
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200510071813.0 | May 2005 | CN | national |