The present invention relates in both a method and apparatus for noninvasive arterial blood pressure measurement and individualized rectifying technology for beat-to-beat blood pressure measurement.
Noninvasive blood pressure (BP) measurement is the technology that measures the BP indirectly by the arterial vessel wall beat or arterial volume. There are two types of noninvasive BP measurement technology: intermissive measurement and continuous measurement. Intermissive measurement can get the value of BP at different time points. But due to the consistent change of BP between every two heart beats and every two time points, the systolic pressure and diastolic may not represent the meaningful value, of course, this two values relate to different heart beats. Continuous measurement technology, which measures the BP without intermission, can provide the beat-to-beat BP or continuous BP oscillation. It is very important to realize the noninvasive continuous BP measurement. But, until now, there is not an accurate method that can achieve the aim.
BP measurement in according to the pulse wave transit velocity (PWTV) is a type of noninvasive continuous BP measurement method. In 1922, Bazzett discovered that arterial pressure related to the PWTV or pulse wave transit time (PWTT), in addition to arterial volume and arterial flexibility. In 1957, Lansdown pointed that PWTT and arterial BP present linear relationship to some extent and this relationship is stable for a given subject in a period of time. Moreover, the coefficients that descript linear relationship between PWTT and BP vary violently for different subjects with different arterial vessel tissue structure. But in past studies, the BP of different subject was general evaluated through the same coefficient, so the result can be distorted by errors.
An equation describing the relationship between the BP and PWTT for a given subject can be deduced in terms of the linear relationship between them:
BP=a+b×PWTT (A)
In this formula, b is regressing coefficient to be estimated which varies in different subjects. But for a given subject and in a short period, a and b are stable. Previous analyze shows that to evaluate arterial BP, the coefficient a and b for a given individual must be obtained firstly. After that, BP can be computed By the PWTT (or PWTV). The coefficient a and b need to be rectified by means of individualized regressing technology, so the BP computed by the regressing equation (A) can fit individual condition well.
In principle, evaluating two parameters needs two group independent experiment data. PWTT and mean arterial pressure in the quiet condition can be obtained, so coefficient a, i.e. intercept, is easy to get. To b=ΔBP/ΔPWTT, i.e. slope, is always estimated by altering BP to get two groups of data. But, 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 linear relationship in equation (A) is consistent.
Yu Mengsun also believed that when body posture changed (for example, supine and elevating leg), PWTT in the elevating leg would change. It is because that the change of body posture alters the pressure in some vessel and then makes PWTV different from that of normal state. If experiment data in normal status and posture changing status can be obtained, the coefficient b will be estimated from these data. This method can rectify parameters more accurately, but multi-group information in relate to the beat-to-beat BP cannot be got continuously when the body posture changed.
The purpose of the present invention is to offer a method and device that can measure the beat-to-beat arterial blood pressure by the information of arterial blood pressure. The invention also propose an individual rectifying technique which makes the blood pressure estimated by using continuous pulse wave measurement to be according with the individual reality.
To resolve the problem above, 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 value of cuff pressure P and corresponding Korotkoff's sound delay time TK; getting function relation TK=H(P) between Korotkoff's sound delay time and of cuff pressure.
(2) Calculating Korotkoff's sound delay time 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 phase compared with the change caused by blood pressure, using the equation relation TK=H(P) between Korotkoff's sound delay time TK and cuff pressure P. We can estimate the change of blood pressure, which is corresponding to the Korotkoff's sound delay time.
The Korotkoff's sound delay time mentioned above is the time that the Korotkoff's sound arrived the fixed reference point within the same cycle of a heartbeat. The fixed reference point can be the ECG R wave peak (
The equipment to implement the method above comprises: the cuff, the inflating unit and deflating unit for the cuff, the cuff pressure sensor, the Korotkoff's sound sensor, ECG electrode. The ports of output signal of the cuff pressure sensor and Korotkoff's sound sensor connected with the microprocessor through the signal conditioning circuit. The ECG electrode connected with the microprocessor, which has the printing and data display equipment.
The individual rectifying technique according to the said invention is:
Constructed a regress equation between 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 b is the regress coefficient. After individualized rectified the parameters a and b, based on the continuous measurement of pulse wave transit time, using the equation above, we estimated the continuous change of the individual blood pressure. The individual rectifying method for b is:
(1) Wrapping the cuff around the trunk or limb of the given subject, getting a series value of cuff pressure P and corresponding Korotkoff's sound delay time TK, then we can get the function relation 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 function relation TK=H(P) between Korotkoff's sound delay time and variety of cuff pressure, we can estimate the change value of blood pressure corresponding with 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) According to the data measured in step 2 and 3, calculating the regress coefficient between the change of mean arterial pressure ΔBP and the change of pulse wave transit time ΔPWTT, then we can obtain individual rectified parameter b.
In step 2 of the individual rectifying method, the mean arterial pressure Pm is the preference for the cuff pressure.
Another method of individual rectifying is: during the measurement of the Korotkoff's sound delay time when cuff pressure in the step 2, by acting the behavior that can alter the blood pressure of the subject and do not change the characteristic of vascular wall, we can enhance the change of blood pressure between different measurement points.
The behavior that can alter the blood pressure of the subject is deep breathing.
The equation above-mentioned that was constructed for the subject is a regress equation between the PWTT and BP. The method in present invention is the same with the equation between PWTV (pulse wave transit velocity) and BP, or other linear regress equations that have different performs but the same essence.
The present invention is designed according to the study about the relationship of Korotkoff's sound delay time TK, the cuff pressure P and arterial blood pressure BP. The following is the introduction of the invention principle.
When measuring blood pressure by the conventional stethoscope method, we firstly inflate the cuff until the cuff pressure exceeding to systolic blood pressure when artery is impacted and shuts off, there is no blood flow in the artery. Then deflate 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 other than upright rising. So along with the decreasing of the pressure inside cuff, within each heartbeat cycle, the earlier artery open, the earlier Korotkoff's sound appears. And also according to the fixed reference point in each corresponding cycle (such as R wave in electrocardiogram or the rising point of the pulse wave inside the cuff or some other selected reference point), Korotkoff's sound delay times are shorter and shorter.
We can draw a conclusion that Korotkoff's sound delay times decrease gradually along with the dropping of the cuff pressure, so the function 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 function relationship TK=H(P) is obtained when cuff pressure is descending, 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, 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 change when blood pressure is stable is the same in size and inversely in direction of that induced by blood pressure change when cuff pressure is stable.
According to the above-mentioned orderliness, the present invention estimates the blood pressure change of each heartbeat cycle corresponding to each Korotkoff's sound by observing Korotkoff's sound delay time under certain cuff pressure. The method can also evaluate the blood pressure of each cycle.
The individualized rectifying technology of continuous artery blood pressure monitoring regress equation is established on the finding that the corresponding change of artery 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 artery blood pressure BP is:
BP=a+b×PWTT (A)
Before using PWTT to measure BP, the parameters a and b must be calculated. 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 different blood pressure level, the parameter b can be obtained. There are two factors:
1. To change the value of the BP;
2. To detect the change of the BP.
In fact, the human's BP is changing at any moment. But the instantaneous change of BP can't be measured non-invasively with the known technique. The present invention can estimate the change of BP per beat through the Korotkoff's sound delay time, and measure individual rectifying parameters using instantaneous change of BP.
Otherwise, the change of BP and PWTT are so small that the error of calculation will increase inescapably. 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 try to control breath or some other actions to alter the subject's BP.
The work process of the present invention is: the cuff pressure P can be increased or decreased by inflation unit. In this process, Korotkoff's sound sensor measures the arrived time of sound, and sends it to the CPU. At the same time, heart beat signal is also sent to the CPU through electrodes and detecting circuit. Thereby the value of interval TK that is from every fixed reference point to Korotkoff's start-point in the same cycle can be gotten. And the function TK=H(P) in said invention can be obtained. Keeping the cuff pressure at a fixed value, measuring Korotkoff's sound delay time TKm, using function TK=H(P) to get the blood pressure variance in the current heart cycle compared to the initial measurement when the function TK=H(P) was obtained.
The method and equipment in present invention can fulfill beat-to-beat artery blood pressure estimation, and create a new way for individualized rectifying technology of continuous artery blood pressure monitoring regress equation. This technology can use instantaneous change of BP to get individual rectifying parameters, and 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 apply deep breath to enhance the blood pressure variety of subject in individualized rectifying method, which can improve the accuracy of rectifying and reduce the errors and is safe and reliable for the subject.
The following is about how to measure the arterial BP value of certain heartbeat:
1. Wrapping the cuff around a subject's upper arm as shown in
2. Recording a series of Korotkoff's sound delay time value TK and cuff pressure value P during deflation, then construct function 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 that the Korotkoff's sound delay time is shortening as the cuff pressure decreases after quadratic line approximation about these discrete data. And according to TK=H(P), the function g(P) about the dTK/dP value of each point is obtained too. As show in
Based on these individualized functions said, the following data can be measured and calculated.
3. Measuring Korotkoff's sound delay time value TKm when the cuff pressure is at certain known value Pm that is between systolic blood pressure SBP and diastolic blood pressure DBP. Based on the said function TK=H(P), obtaining Korotkoff's sound delay time TKm0 when the cuff pressure value is equal to Pm, and calculate the difference ΔTKm between TKm and TKm0.
4. Calculating the g(Pm) value as the cuff pressure value is equal to Pm, according to the said function 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 changes 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 BP variance ΔBPm and the mean blood pressure value BP0 that is used to get the function TK=H(P).
The principle of the said method is follows: If the BP level at the time when the TKm is measured is equal to the BP level BP0 at the time when the function 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 calculate from the fitted curve TK=H(P) while the 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 value TK and corresponding cuff pressure value P, and construct function TK=H(P) as in embodiment 1. After two order fitting about these discrete data, establishing the curve TK=H(P) that Korotkoff's sound delay time value TK changed with cuff pressure value P.
2. Calculating the difference value of the fitted curve TK=H(P) in said, and obtains a new function g(P) that represents the Korotkoff's sound delay time change with one unit pressure (1 mmHg). As shown in
3. Maintaining the cuff pressure at the level P0 that is approximate equal to mean blood pressure, and then getting a series of beat-to-beat Korotkoff's sound delay time T(i) (shown as
4. Calculating the difference T′(i) of the said T(i) (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 data g(Pi)=dTK/dP. Therefore, calculate the dynamic BP change value ΔBP(i) of each beat by the coefficient g(Pi) corresponding to the T′(i) (shown as
ΔBP(i)=T′(i)/g(Pi)
Add up ΔBP(i) of each beat, and obtain the beat-to-beat continuous BP change value BP(n) (show as
n=1 . . . m−1,n is the heartbeat number during the cuff pressure keeps approximate stable, BP is the dynamic blood pressure. According to the equation above, 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 individually rectifying of said arterial blood pressure measurement.
The regress equation of PWTT and beat-to-beat arterial blood pressure BP is:
BP=a+b×PWTT (A)
BP means blood pressure, PWTT means pulse wave transmit time, b means regress coefficient to be defined.
The method of individually rectifying of coefficient a and b is as follows:
(1) Putting the cuff and Korotkoff's sound sensor to the distal of the cuff on one of the upper arms of the subject, measuring the blood pressure by auscultatory method, get the systolic blood pressure and diastolic blood pressure, calculate the mean artery pressure BP0 by empirical formula, (which can also be measured by oscillometrc method) and record the synchronous pulse wave transmit time (PWTT0).
(2) Getting a series of pulse wave transmit times and cuff pressures in the whole deflating process in the same way as (1), building the function TK(P); getting the curve of Korotkoff's sound delay time TK changing with cuff pressure P, TK (P), calculating the difference of the curve, get the Korotkoff's sound delay times changing with each per unit pressure (1 mmHg), forming a new series function g(P). As shown in
(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 time and corresponding pulse wave transmit times. In measurement process, make the subject have deep breath, getting two group data arbitrarily, calculate the difference of Korotkoff's sound delay times in different time, ΔT. Based on the series function g(P), calculating the value g of corresponding cuff pressure, using ΔT to estimate the variation of arterial blood pressure ΔBP1; calculating the synchronous pulse wave transmit time ΔPWTT1.
The regressive coefficient b1=ΔBP1/ΔPWTT1.
In the same way, get the b2, b3 . . . .
Calculate the mean of the series b1, b2, b3 . . . , thus the regressive coefficient can represent the true individual parameters.
In addition, calculating the regressive coefficient using the BP signal and the PWTT signal, and the regressive coefficient is the coefficient b of the blood pressure function.
In this embodiment, the controlling unit of inflating and deflating connects to CPU. The CPU controls the inflating and deflating, the analog signal output from the cuff pressure sensor were amplified, low-pass and band-pass filtered, and converted to digital signals and input to CPU; the output signal of Korotkoff's sound sensor was amplified, filtered, converted to digital signal and input to CPU, electrocardiogram circuits connect electrode and CPU.
The CPU identifies the characteristic points of the Korotkoff's sound signal and the pulse wave signal in the cuff (As shown in
This is a continuation-in-part application of patent application Ser. No. 11/775,870 filed on Jul. 11, 2007, now abandoned which is pending now, and the entirety of which is incorporated by reference herein and made a part of this specification.
Number | Name | Date | Kind |
---|---|---|---|
4216779 | Squires | Aug 1980 | A |
4408614 | Weaver | Oct 1983 | A |
4974597 | Walloch | Dec 1990 | A |
5322069 | Gallant | Jun 1994 | A |
5560365 | Ogura | Oct 1996 | A |
5634467 | Nevo | Jun 1997 | A |
20030220577 | Bartels | Nov 2003 | A1 |
20050261597 | Kolluri et al. | Nov 2005 | A1 |
20080033310 | Yu et al. | Feb 2008 | A1 |
Number | Date | Country | |
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20120283584 A1 | Nov 2012 | US |
Number | Date | Country | |
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Parent | 11775870 | Jul 2007 | US |
Child | 13466086 | US |