WO2009013287A1 - Procédé pour déterminer une modification quasi continue de la pression sanguine dans un flux sanguin pulsatile - Google Patents

Procédé pour déterminer une modification quasi continue de la pression sanguine dans un flux sanguin pulsatile Download PDF

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Publication number
WO2009013287A1
WO2009013287A1 PCT/EP2008/059584 EP2008059584W WO2009013287A1 WO 2009013287 A1 WO2009013287 A1 WO 2009013287A1 EP 2008059584 W EP2008059584 W EP 2008059584W WO 2009013287 A1 WO2009013287 A1 WO 2009013287A1
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WIPO (PCT)
Prior art keywords
blood pressure
change
rate
course
blood
Prior art date
Application number
PCT/EP2008/059584
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German (de)
English (en)
Inventor
Thomas Hübner
Michael Alt
Original Assignee
Enverdis Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Enverdis Gmbh filed Critical Enverdis Gmbh
Priority to EP08786320A priority Critical patent/EP2166933A1/fr
Publication of WO2009013287A1 publication Critical patent/WO2009013287A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation

Definitions

  • the invention relates to a method for the non-invasive determination of a quasi-continuous change in blood pressure in a pulsatile bloodstream.
  • Pulse wave velocity is the rate at which a heart pulse propagates from the heart towards the akralen blood vessels.
  • Pulse wave velocity is the rate at which a heart pulse propagates from the heart towards the akralen blood vessels.
  • Moens and Korteweg describes the pulse wave velocity in a cylindrical tube model as a function of the parameters of the vessel wall:
  • the modulus of elasticity of the blood vessel is - as empirical studies show - dependent on blood pressure. In the range 60-180 mmHg, a linear dependence can be assumed as a first approximation:
  • the blood pressure p increases with an increase in the pulse velocity in the pressure range of interest.
  • a method used in practice for determining the pulse wave velocity relates to the determination of the pulse transit time, starting from the occurrence of the R wave in the ECG until the impact of the pulse wave on a sensor on an angled body part, eg an ear clip.
  • This measured pulse transit time is used to calculate pulse velocity, from which in turn the blood pressure can be calculated.
  • the relationship between blood pressure and pulse wave velocity is due to the fact that the vasomotor increase in the wall tension of the arteries on the one hand changes the blood pressure, but also the speed of Incweile, ie the wave, which spreads from the heart in the Arterien stii ⁇ den. As the wall voltage increases, the pulse wave velocity is also increased.
  • the relationship between blood pressure and pulse wave velocity is actually more complex in practice.
  • the pressure generated primarily by the work of the heart also plays a role.
  • Non-invasive determination of blood pressure by inflated pressure cuffs is possible. Among other things is the
  • Voiumenkompensationsmethode known in which a finger cuff, in which a photoplethysmographic sensor and a pressure regulator are integrated, is used.
  • the pressure regulator is controlled in such a way that with reduced light flow (increased vessel diameter due to high pressure in the artery during systole), a back pressure is generated.
  • the back pressure is reduced by the pressure regulator.
  • the cuff pressure corresponds to the rantraarterial pressure, so that a determination of the blood pressure can be made.
  • Another known method is the oscillatory method.
  • the pressure of an inflatable cuff for example applied to the patient's upper arm, is determined, on which the blood pulse strikes. From the course of Registered pulse amplitudes when releasing the Ma ⁇ schetten réelles can be closed to the blood pressure.
  • the object of the invention is to provide a method with which a quasi-continuous change in blood pressure in a bloodstream can be determined simply and reliably.
  • the time course of a volume pulse of the blood in the bloodstream is measured.
  • the first derivative is formed over the time of the measured Volumenpulsverlaufs. From this first derivative, the time course of a transversal rate of change of the cross section of the bloodstream is determined.
  • a quasi-continuous blood pressure value is determined directly from this rate of change of the bloodstream cross section.
  • the shape and amplitude of the pressure pulse are influenced, inter alia, by the extensibility of the arterial vascular system.
  • the aorta and large arteries act like a "wind cauldron" during the ventricular systole, attenuating the pressure fluctuations produced by the heart, and the pressure wave propagating from the heart along the vessels is increasingly attenuated due to the extensibility of the vessel walls in the more distant arteries.
  • the amount of amplification attenuation depends on the material properties of the blood vessels, the mean pressure in the vessels and the length and volume of the vessels.
  • the strain-voltage curve for blood vessels is not a straight line (see DUCK, FRANCIS A.
  • the measured volume pulse course which is also referred to as a plethysmogram, represents a change in volume and thus also the change in the cross section of the blood vessels.
  • the calculation of the first derivative of the measured volume pulse course is not only for a single time, but over the entire time course. From this curve, the course of the transverse rate of change of the cross section of the Biutbahn can be determined at the site over time.
  • the method according to the invention particularly preferably comprises carrying out a linearization step by measuring a reference blood pressure in a conventional manner, in particular, once, this reference blood pressure _ ⁇ _ j
  • the above-mentioned blood pressure measuring methods can be used for example for measuring the reference blood pressure.
  • two Referenzmessu ⁇ gen be performed, wherein in each reference measurement in each case once the reference blood pressure and once the reference rate of change of the blood vessel diameter is measured.
  • the first reference measurement can take place in a resting state, while in the second reference measurement by stress or by administration of appropriate medicaments a significant systolic blood pressure change, preferably of at least 20%, is generated.
  • the stress can be generated, for example, by squats or other physical activities.
  • the described reference measurements linearize the determined results for the quasi-continuous blood pressure curve.
  • the nonlinear dependencies between the blood pressure and the rate of change of the blood vessel diameter that are present as a function of the respective physiological conditions can also be adapted by a higher order polygon.
  • further parameters from the measured volume pulse course and / or the profile of the first derivative of the volume pulse course are used to determine the blood pressure. These may be, for example, maxima, minima or other prominent locations of the volume pulse profile. Furthermore, temporal differences between these prominent points of the volume pulse course and / or integrals between these points can be determined.
  • the mentioned or further parameters can be investigated by means of linear or non-linear methods, in particular by determining the covariance and / or different correlation methods. The use of further suitable known mathematical methods is possible. As an additional or alternative Optimization methods can be used, for example, regression analyzes and / or neural networks.
  • a continuous blood pressure curve is determined, which in particular comprises a systolic, a diastolic and a mean blood pressure value.
  • a measured Volumenpuis course at a measuring point of the blood vessel is usually divided into a first phase (systole) and a second phase (diastole).
  • a value for the derivation of the Volumenpuisverlaufs can be determined at a prominent point of the Volumenpulsverlaufs during systole, which can be assigned according to a transverse rate of change of the cross section of the bloodstream.
  • a systolic blood pressure can now be determined from this rate of change of the bloodstream cross section for this particular time.
  • a diastolic blood pressure In order to determine a diastolic blood pressure, it is accordingly possible to determine a value for the derivation of the Voiumenpulsverlaufs during the diastolic phase, which can be assigned to a corresponding value for the transverse rate of change of the cross-section of the bloodstream and a value for the Pulwellen ⁇ york at this time. Thus, also a diastolic blood pressure can be determined. Further possibly required blood pressure values at other times can be correspondingly determined by each determining a value for the derivation of the volume pulse profile together with the further required values for any other time.
  • the measuring location for measuring the time profile of the volume pulse is formed as a small measuring point. This means that the measurement of the volume pulse profile does not take place over a certain distance, but only a very small measuring segment is considered.
  • the measurement of the time course of the volume pulse takes place at an akralen body part, for example, the earlobe of a patient, others suitable measuring points, such as the fingertip, can also be selected.
  • the volume pulse profile in the blood vessel is detected photoplethysmographically.
  • a body part to be examined for example a human finger or the earlobe
  • the radiation component of the measuring radiation reflected by the body part to be examined is detected. From the time course of the detected reflected radiation component of the measurement radiation, the time profile of the volume pulse at the measurement location is determined.
  • the measurement radiation transmitted through the body part to be examined can be detected.
  • the determination of the time profile of the volume pulse can then be based on the measured reflected and transmitted radiation component of the measurement radiation, which is described in particular by the Lambert-Beer law:
  • Lambert-Beer's law shows how the intensity of radiation passes through an absorbing material as a function of the radiation intensity Concentration of the substance behaves. The extinction is given as the logarithm of the ratio of the transmitted to the incident light
  • a suitable device for determining a Volumenpuisveriufs in a Biutbahn is described in the also filed by the Applicant German patent application "Apparatus for the continuous non-invasive determination of concentrations of various blood components".
  • the method according to the invention it is sufficient for the method according to the invention to determine the volume pulse course of a single blood constituent.
  • the device described in said application need only comprise a radiation source for emitting a single wavelength.
  • Other suitable devices may also be used to determine the volume pulse profile,
  • FIG. 1 is a schematic representation of a device for determining a volume pulse course in a bloodstream
  • Fig. 2 is a graphical representation of a measured
  • 3 is a graphical representation of the calculated first derivative of a measured volume pulse over time with various prominent points
  • Fig. 4 is a graphical representation of a measured
  • Volume pulse course and its first derivative over time shows a graphic representation of the first derivation of a measured volume pulse profile with different prominent points
  • FIG. 5 shows a graphic representation of the first derivation of a measured volume pulse profile with different prominent points
  • Fig. 6a, 6b is a graphical representation of various items
  • a device for the continuous determination of a volume pulse curve in a bloodstream has a radiation source 12 for emitting a measuring radiation 14 in the direction of a body part 16 to be examined (FIG. 1). More preferably, the body part 16 to be examined is a human finger. Alternatively, however, for example, the earlobe of a person, as well as other suitable body parts can be used for measurement.
  • the device 10 has a first radiation receiver 18 for receiving the radiation 20 reflected by the body part 16 to be examined.
  • the first radiation receiver is arranged in the illustrated embodiment in the first receiving element 28.
  • the device 10 further comprises a second radiation receiver 22 for receiving the radiation 24 transmitted through the body part 16 to be examined.
  • the second radiation receiver 22 is arranged in the illustrated embodiment in the second receiving element 30, which is opposite to the first receiving element 28.
  • Opposite in this context means that the two receiving elements 28, 30 and the first 18 and the second 22 radiation receiver are arranged such that, for example, a finger 16 can be positioned between them.
  • reflection measurement is shown schematically.
  • the radiation source 12 emits a measuring radiation 14.
  • the emitted measuring radiation 14 is at least partially reflected by the body part 16 to be examined, so that a portion of the measuring radiation 14 is reflected as reflected radiation 20 in the direction of the first radiation receiver 18.
  • the measurement of the radiation 24 transmitted by the body part 16 to be examined is likewise shown schematically in FIG.
  • the radiation source 12 emits a measuring radiation 14 in the direction of the body part 16 to be examined. At least a portion of the radiation 14 passes through the body part 16 to be examined and impinges on the second radiation receiver 22 as transmitted radiation 24.
  • the first 18 and the second 22 radiation receiver are preferably designed as photodiodes.
  • the device further comprises a calculation device 26, which is connected to the first 18 and the second 22 Strahiungsempfnatureer. The measured reflected 20 and transmitted 24 radiation components are fed to the calculation device 26 so that they can evaluate the determined curves on the basis of the measured radiation components.
  • the radiation fraction transmitted through the body part in comparison to the emitted radiation can in principle be calculated by the Lambert-Beer law.
  • inventive method for Blood pressure measurement preferably determines amplitudes at prominent points of the Volume ⁇ puJsveriaufs and its derivative, in particular maxima and minima, temporal differences between the prominent points and / or integrals between the prominent points. Standardization of the curves to a defined amplitude and possibly to a defined heart rate may also be expedient, so that the absolute intensity values to be calculated according to the Lambert-Beer law are dispensable.
  • the calculation device 26 can be designed, for example, as a PC on which a specific software program for carrying out the aforementioned calculations runs. In particular, these calculations can also be made on a PC at a different time than the measurement of the transmitted and reflected radiation.
  • the calculation steps essential to the invention take place independently of the physical detection of the patient features described so far.
  • the further described procedure steps can also be carried out without an interaction with the body of a patient, i. that their implementation does not require the presence of a patient's body.
  • the radiation source 12 is preferably formed as an LED and emits light of a wavelength that is particularly well absorbed by blood or its constituents. This may be, for example, the wavelength 805 nm +/- 10 nm.
  • FIGS. 2 and 4 By choosing a suitable wavelength, it is possible using the described device to determine a volume pulse course in a bloodstream, as shown in FIGS. 2 and 4 is shown.
  • This volume pulse course is measured at a measurement point which is limited in its local extent, for example the earlobe or the human finger, and therefore describes the temporal change of the volume of the blood pulse at this measurement point
  • Various salient points in the volume pulse curve that can be used for further calculations are also shown in FIG.
  • these prominent points can also be included in the calculation of the blood pressure from the volume pulse course.
  • differences on the time axis between different prominent points for example the value "Diff 1" between the points "xl" and "x2" can be taken into account.
  • FIG. 2 The course of the first derivative of the volume pulse profile shown in FIG. 2 is shown in FIG. This is the speed of the volume flow change. Again, several prominent points of the course of the derivative shown are marked. These can also be taken into account in the calculation of blood pressure »
  • the upper part of FIG. 4 also represents a measured volume pulse curve, while the lower part of FIG. 4 shows the profile of the first derivative of the volume pulse curve of the upper part of FIG. 4.
  • the solid line represents the course of a low blood pressure, while the dashed line represents the course of a high blood pressure.
  • the transverse rate of change of the cross section of the bloodstream at a high blood pressure is significantly higher at a low blood pressure.
  • these parameters are also determined in the reference measurement or in the reference measurements as reference parameters. Based on the changes in these parameters from each heartbeat to the baseline value of the reference measurements, changes in blood pressure can be determined. Thus one obtains a quasicontinuous change in pressure from heartbeat to heartbeat in relation to the reference values. Since the described reference parameters can be detected both during systole and during diastole, it is possible to determine the change of these parameters at each time of systole and diastole, so that a corresponding blood pressure value can be determined for this time. In contrast, in a conventional blood pressure measurement, for example, with a cuff, the blood pressure can only be determined approximately every minute. As an application example of the invention, FIG. 7 shows the relationship between a parameter determined from the first derivation of the rate of change of the blood vessel diameter and the systolic blood pressure.
  • One possible parameter that correlates with blood pressure is the time difference between the maximum value and the following inflection point of the first derivative of the volume pulse curve.
  • This quantity referred to as "Parameter 1” corresponds to the time difference between the points "x2" and “xl2” in Figure 3
  • the correlation between "Parameter 1" and the systolic blood pressure determined by a reference procedure ("Finapress") is shown in Fig. 7.
  • the respective points (stars) represent the frequency of these
  • the percentages of the graph are plotted on the abscissa of the graph: the percentage deviation of the parameter l u from its original value (obtained at time 0):
  • the biometric pressure determined on the basis of the "parameter 1"("X") at 2 points is determined by a conventional method of blood pressure measurement (pressure values p 0 , pi)
  • the 2 points correspond to 2 different points in time at which the biological pressure, which may be influenced by the physical or mental stress of the patient or by medication, should differ as much as possible. This comparison can be made by the following mathematical relationships (Example after Fig.7) are described:
  • parameter 2 Another parameter that can be used to determine the blood pressure is parameter 2, namely the area of the first derivative of the pulse curve between its inflection point (time xl2 in FIG. 3) and the zero passage (time x4 in FIG. 3).
  • the calculation of the parameters p 0 , D and Z can preferably be achieved by assigning the alternatively determined pressures pi, p 2 and p 3 to the associated values of the "parameter 2" (Y 1 , Y 2 and Y 3 ) at 3 different times ( t i; t 2 and t 3 ) At the various times, the "parameter 2" should differ as much as possible:
  • This system of 3 independent equations allows the determination of the 3 unknown parameters p 0 , D and Z.
  • the invention further relates to a method for determining baroreflex sensitivity using the previously described noninvasive method for quasi-continuous blood pressure measurement, the aim of determining baroreflex sensitivity is to provide a measurement or analysis method which makes possible a risk stratification of patients, in particular after a heart attack, easy to do. In particular, it should be possible to perform this measurement routinely in clinical diagnostics.
  • the method according to the invention for determining the baroreflex sensitivity can therefore comprise the method steps described so far for the non-invasive determination of a quasicontinuter surface change in blood pressure in a pulsatile bloodstream. Furthermore, as part of this method, a pulse detection takes place, so that the determined blood pressure values a respective Pulse value can be compared. This results in gradients, as shown in Fig. 6a and Fig. 6b.
  • Figure 6a shows as a dashed line (SAP) the course of the change in systolic blood pressure (beat to beat registration) over time, the solid line represents the change in the RR interval over time.
  • SAP dashed line
  • Increased blood pressure caused by a physical stress or physical impact on the patient, with such a provoked blood pressure increase is of course not for therapeutic purposes.
  • the values between the two vertical dashed lines are used. This results in a regression analysis of the blood pressure associated changes in the RR IntervaI! S of FIG. 6b.
  • the increase in blood pressure is associated with a continuous prolongation of the RR interval.
  • the slope of the regression line is about 20 ms / mmHg, which corresponds to normal baroreflex sensitivity.
  • the heart rate is now detected, wherein the heart rate is preferably calculated from a simultaneously registered ECG.
  • a targeted influencing of the blood pressure for example by medication, by physical effects on the patient (special storage, negative pressure generation on the legs or neck, temperature effect) or by mental impact.
  • the detection of spontaneous blood pressure changes may be used to determine baroreflex sensitivity. The determined values can be evaluated statistically, for example by a determination of -? P -

Abstract

L'invention concerne un procédé pour déterminer de manière quasi continue la pression sanguine dans un flux sanguin dans lequel on mesure d'abord la variation dans le temps du pouls volumique sanguin dans un flux sanguin. On déduit ensuite la durée de variation du pouls volumique mesuré. A partir de cette déduction de la variation du pouls volumique, on détermine la variation de la vitesse de modification transversale de la section transversale du flux sanguin. En étalonnant la vitesse de modification transversale de la section transversale du flux sanguin en se basant sur des valeurs de pression sanguine déterminées de manière classique, on peut déduire la variation quasi continue de la valeur de pression sanguine à partir du pouls volumique sanguin.
PCT/EP2008/059584 2007-07-24 2008-07-22 Procédé pour déterminer une modification quasi continue de la pression sanguine dans un flux sanguin pulsatile WO2009013287A1 (fr)

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EP08786320A EP2166933A1 (fr) 2007-07-24 2008-07-22 Procédé pour déterminer une modification quasi continue de la pression sanguine dans un flux sanguin pulsatile

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EP07113007.4 2007-07-24
EP07113007 2007-07-24

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102019102178A1 (de) * 2019-01-29 2020-07-30 Fresenius Medical Care Deutschland Gmbh Verfahren zum Bestimmen eines Blutdruckwerts eines Patienten, Blutdruckmessgerät und Dialysesystem
WO2022038364A1 (fr) * 2020-08-21 2022-02-24 Bluedop Medical, Ltd Surveillance continue de la pression artérielle
US11607198B2 (en) 2018-01-02 2023-03-21 Bluedop Medical, Ltd. System for determining peripheral artery disease and method of use
US11660063B2 (en) 2015-11-18 2023-05-30 Bluedop Medical, Ltd. System for determining peripheral artery disease and method of use
US11678808B2 (en) 2009-03-13 2023-06-20 Bluedop Medical, Ltd. Haemodynamic data estimation apparatus and method of use

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Publication number Priority date Publication date Assignee Title
CH547088A (de) * 1972-05-09 1974-03-29 Borgnis Fritz Vorrichtung fuer medizinische zwecke zur bestimmung mindestens einer ableitung einer funktion.
US5269310A (en) * 1990-09-06 1993-12-14 Spacelabs Medical, Inc. Method of measuring blood pressure with a plethysmograph
US5533511A (en) * 1994-01-05 1996-07-09 Vital Insite, Incorporated Apparatus and method for noninvasive blood pressure measurement
US5882311A (en) * 1995-06-05 1999-03-16 Pwv Medical Pty Ltd. Calibration for blood pressure pulses

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CH547088A (de) * 1972-05-09 1974-03-29 Borgnis Fritz Vorrichtung fuer medizinische zwecke zur bestimmung mindestens einer ableitung einer funktion.
US5269310A (en) * 1990-09-06 1993-12-14 Spacelabs Medical, Inc. Method of measuring blood pressure with a plethysmograph
US5533511A (en) * 1994-01-05 1996-07-09 Vital Insite, Incorporated Apparatus and method for noninvasive blood pressure measurement
US5882311A (en) * 1995-06-05 1999-03-16 Pwv Medical Pty Ltd. Calibration for blood pressure pulses

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11678808B2 (en) 2009-03-13 2023-06-20 Bluedop Medical, Ltd. Haemodynamic data estimation apparatus and method of use
US11660063B2 (en) 2015-11-18 2023-05-30 Bluedop Medical, Ltd. System for determining peripheral artery disease and method of use
US11607198B2 (en) 2018-01-02 2023-03-21 Bluedop Medical, Ltd. System for determining peripheral artery disease and method of use
DE102019102178A1 (de) * 2019-01-29 2020-07-30 Fresenius Medical Care Deutschland Gmbh Verfahren zum Bestimmen eines Blutdruckwerts eines Patienten, Blutdruckmessgerät und Dialysesystem
WO2022038364A1 (fr) * 2020-08-21 2022-02-24 Bluedop Medical, Ltd Surveillance continue de la pression artérielle

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