EP4132352A1 - Procédé et dispositif de détermination de l'état volémique et du tonus vasculaire - Google Patents

Procédé et dispositif de détermination de l'état volémique et du tonus vasculaire

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Publication number
EP4132352A1
EP4132352A1 EP21719051.1A EP21719051A EP4132352A1 EP 4132352 A1 EP4132352 A1 EP 4132352A1 EP 21719051 A EP21719051 A EP 21719051A EP 4132352 A1 EP4132352 A1 EP 4132352A1
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EP
European Patent Office
Prior art keywords
computer
ppg
determining
signal
components
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Legal status (The legal status 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 status listed.)
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EP21719051.1A
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German (de)
English (en)
Inventor
Peter KREMEIER
Gerardo Tusman
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Conscientus Aps
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Loewenstein Medical Technology SA
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Publication of EP4132352A1 publication Critical patent/EP4132352A1/fr
Pending legal-status Critical Current

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    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02416—Measuring pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
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    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
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    • A61B5/02028—Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
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    • A61B5/026—Measuring blood flow
    • A61B5/0295—Measuring blood flow using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
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    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
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    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
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Definitions

  • volemic status and the vascular tone of the hemodynamic system of a patient cannot be determined or can only be determined invasively.
  • the photoplethysmographic (PPG) signal of pulse oximetry provides non-invasive information about oxygen saturation and the pulse wave.
  • the PPG waveform represents the change in blood volume in the tissue being monitored (usually the fingers) during a heartbeat.
  • This pulse flow wave is strongly influenced and modulated by vascular interactions. For example, forward and reverse pulse pressure waves can be seen in the PPG signal.
  • Pulse oximeters for example, lack an output of the unfiltered raw signal and an output of measured values on a heartbeat-to-heartbeat basis (beat-to-beat basis) and a high temporal resolution.
  • the invention relates to a method for determining the volemic status and / or the vascular tone of the hemodynamic system, the method comprising; Sensory detection of a photoplethysmography (PPG) signal from a living tissue, the PPG signal having an alternating AC component as the PPG amplitude and a DC component as the PPG baseline,
  • PPG photoplethysmography
  • the method can alternatively or additionally be designed so that the photoplethysmography (PPG) signal from one or more of the following photoplethysmographs, a pulse oximeter, a transmission optical sensor, a reflective photo-optical sensor, a pressure transducer, a tonometry device, a strain gauge, a Ultrasound device, an electrical impedance measuring device, a blood pressure monitor, an EKG device and a camera / detector system is recorded.
  • the method can be designed in such a way that the computer analyzes the photoplethysmography (PPG) signal using the first or second derivative (d2DVP / dt2) of the PPG.
  • the method can be designed in such a way that the computer analyzes the signal from photoplethysmography (PPG) using artificial neural networks, the extraction of periodic components using frequency analyzes or non-linear dynamic analyzes.
  • PPG photoplethysmography
  • the method can be designed in such a way that the determination of a pulse frequency from the AC component includes:
  • the computer identifying a plurality of signal peaks within the AC component
  • the method can be designed in such a way that the determination of a pulse strength metric from the AC component comprises:
  • the computer identifying a plurality of signal peaks within the AC component; and identifying, by the computer, an amplitude for each of the plurality of signal peaks.
  • the method can be designed in such a way that the determination of an average amplitude for at least part of the plurality of amplitudes by the computer.
  • the method can be designed in such a way that the computer analyzes the waveform of at least one AC component in order to identify at least one or more of a wave amplitude, as the wave distance from bottom to top, expressed on a scale of 0-100%, a forward systolic wave S, a backward diastolic wave D, a dichrotic notch which is determined by the analysis of the first derivative of PPG and separates the forward systolic wave S and the backward diastolic wave D.
  • the method can be designed in such a way that the computer predicts the vascular tone of the hemodynamic system from the waveform of at least one AC component, a normal vascular tone being characterized by a waveform with a certain amplitude, the dichrotic notch between -50% the wave amplitude lies.
  • the method can alternatively or additionally be designed so that the computer predicts the vascular tone of the hemodynamic system from the waveform of at least one AC component, wherein a vasoconstriction is characterized by a low waveform amplitude that relates to the normal PPG amplitude, the dichrotic notch is above 50% of the wave amplitude.
  • the method can be designed so that the computer predicts the vascular tone of the hemodynamic system from the waveform of at least one AC component, with a vasoconstriction being characterized by a low waveform amplitude without dichrotic notch or even with the systolic pulse wave (s) (n) is merged.
  • the method can alternatively or additionally be designed so that the computer predicts the vascular tone of the hemodynamic system from the waveform of at least one AC component, with normal vasodilation due to a high waveform amplitude with the dichrotic notch below 50% of the wave amplitude or even below Zero (negative dichrotic notch).
  • the method can be designed so that the computer predicts the volemia of the hemodynamic system from a shift in the DC component over time, with hypervolemia being predicted when a shift in the DC component occurs over a defined baseline over time .
  • the method can be designed such that the computer predicts the volemia of the hemodynamic system from a shift in the DC component over time, with hypovolemia being predicted when the DC component shifts below a defined baseline over time .
  • the method can be designed such that the computer is further configured to analyze AC components of the PPG signal waveform as a measure of the vascular tone, while a shift of the DC component over time is determined as a measure of volemia.
  • the method can alternatively or additionally be designed so that the computer uses a second PPG sensor in data communication with a living tissue, the second PPG sensor being arranged at a different location on the living tissue compared to the first sensor in order to receive data from the first Validate sensor.
  • the computer uses at least one other sensor 20 and such sensor data, for example an acceleration sensor 21, a tonometer, microscope, pressure or a temperature sensor, to validate data from the first sensor.
  • sensor data for example an acceleration sensor 21, a tonometer, microscope, pressure or a temperature sensor
  • a method wherein the computer uses at least one other sensor and such sensor data, for example electrocardiogram, non-invasive arterial blood pressure, non-invasive arterial pulse flow / pressure waveform, capnography, oxygraphy, in order to provide additional information for predicting the condition of the hemodynamic system.
  • the computer is further configured to receive standard hemodynamic parameters from other sensors for a global assessment of hemodynamics.
  • the method can be designed in such a way that the computer is further configured to check the predicted volemia by including hemodynamic parameters such as the non-invasive arterial blood pressure signal from other sensors 20, BO.
  • the method can be designed such that the computer is further configured to check the predicted vascular tone by including hemodynamic parameters from other sensors.
  • the method can be designed such that the computer is further configured to emit light and to;
  • the method may alternatively or additionally be configured such that the computer is further configured to carry out a PPG contour analysis which identifies the wave amplitude and dichrotic notch position;
  • the method can be designed such that the computer is further configured to determine whether there is a relationship between the AC and the DC component of the PPG signal.
  • the method can be designed such that the computer is further configured to determine blood oxygen saturation from the PPG signal.
  • the method may alternatively or additionally be configured such that the computer is further configured to calibrate the PPG signal by determining a plurality of PPG signals over time while the living tissue is arranged at heart level for a first period of time followed by a second period of time with the living tissue located above the cardiac level followed by a third period of time with the living tissue located below the cardiac level.
  • the method can be designed in such a way that the computer is further configured to generate the PPG signal by determining a plurality of PPG signals via the Time to calibrate while the living tissue is at cardiac level for a first period of time after a second period of time and / or a third period of time.
  • the method may alternatively or additionally be configured such that the computer is further configured to generate the PPG signal by determining a multiplicity of PPG signals over time, determining a multiplicity of AC components of the PPG signals and determining a multiplicity of DC components of the PPG signals while living tissue is located at heart level for a first period, followed by a second period when living tissue is located above heart level, followed by a third period when living Tissue is located below the cardiac level, wherein the computer stores values of PPG signals, including AC and DC components, from the first period, the second period and the third period, the clinical range of normal values as well as the highest and lowest possible limits of PPG signals, including AC and DC components, with respect to vascular tone and volemia for egg to identify a specific patient.
  • the method can be designed so that the computer values PPG signals from the first period as base values and values from the second period as the lower limit for vasodilation and / or hypovolemia and values from the third period as the upper limit for vasoconstriction and / or hypervolaemia stores for a particular patient.
  • the method can be designed in such a way that each time segment lasts as long as necessary to obtain a stable PPG signal.
  • the method can alternatively or additionally be configured such that the computer is further configured, starting with, to predict the volemia status and / or the vascular tone of the hemodynamic system for a particular patient after the calibration has been completed.
  • the method can be designed in such a way that the computer is further configured to apply a rule for alerting or not warning medical personnel based on the actual prediction of the volemic status and / or the vascular tone of the hemodynamic system, the medical Personnel are alerted when the volemic status and / or vascular tone increases or decreases by a predetermined relative or absolute amount.
  • the invention also relates to an apparatus.
  • Apparatus for determining the volemic status and / or the vascular tone of the hemodynamic system comprising; a sensor for detecting a photoplethysmography (PPG) signal from a living tissue, the PPG signal having an alternating AC component as the PPG amplitude and a DC component as the PPG baseline, a computer which is set up and designed to carry out the following procedural steps:
  • PPG photoplethysmography
  • the device for determining the volemic status and / or the vascular tone of the hemodynamic system also comprises at least one sensor with at least one light emitter and at least one light detector, the sensor (light emitter) illuminating living tissue 0 with light of certain wavelengths and from the tissue 0 receives modulated light with the detector, including a computer which determines a photoplethysmography (PPG) signal or light absorption from the signal of the detector, the computer being set up and designed to carry out the following method steps:
  • PPG photoplethysmography
  • the computer of the device analyzes the photoplethysmography (PPG) signal using the first or second derivative (dDVP / dt) of the PPG.
  • the computer is also configured to emit light.
  • the computer is set up and designed to analyze the curve of the PPG wave for maxima, and in particular to identify two maxima which are separated by an indentation, the indentation representing the dicrotic notch.
  • the computer is set up and designed to determine the time delay (DT) between the maxima S and D and to determine a measure for the stiffness of the arteries from the time delay (DT) between the maxima S and D.
  • the computer is set up and designed to determine an amplitude of the first maximum S to and an amplitude of the second maximum D, the computer determining the ratio of the amplitude of the first maximum S to the amplitude of the second maximum D as the systemic vascular resistance.
  • the computer is set up and designed to determine a maximum percentage PPG amplitude which is equal to 00% and submaximal percentage PPG amplitudes in the range of below or above 0%.
  • the computer is set up and designed to determine a vasoconstriction if no dicrotic notch can be identified from the course of the PPG signal and / or to determine vasodilation if a dicrotic notch can be identified from the course of the PPG signal.
  • the computer is set up and designed for
  • the computer determining a plurality of DC components of the PPG signals; the computer determining a DC signal trend over time by comparing at least two DC components;
  • the computer is set up and designed for
  • the computer determining a plurality of AC components of the PPG signals; the computer determining an AC signal trend over time by comparing at least two AC components;
  • the computer is set up and trained to identify a normal PPG shape when the dicrotic notch is between 0% and% of the total maximum PPG amplitude.
  • the apparatus comprising: a computer for receiving a photoplethysmography (PPG) signal comprising an alternating AC component as a PPG amplitude and the DC component as a PPG baseline from a sensor in data communication with a living tissue; Determining, by the computer, a plurality of PPG signals from the living tissue over time;
  • PPG photoplethysmography
  • the computer determines a variety of AC components of the PPG signals.
  • the computer determines a variety of DC components of the PPG signals.
  • the computer determines a variety of AC waveforms from the AC components and identifies differences in AC Waveforms over time by comparing at least two AC waveforms;
  • the invention also relates to a device for determining the volemic status and the vascular tone of the hemodynamic system, the device comprising: a computer for receiving a photoplethysmography (PPG) signal which shows an alternating AC component as the PPG amplitude and the DC Comprises a component as a PPG baseline from a sensor in data communication with a living tissue;
  • PPG photoplethysmography
  • the computer determines a variety of AC components of the PPG signals.
  • the computer determines a variety of DC components of the PPG signals.
  • the computer determines a variety of AC waveforms from the AC components and identifies differences in AC Waveforms over time by comparing at least two AC waveforms;
  • the invention also relates to a system.
  • the system comprises at least one ventilator, a device for determining the volemic status and / or the vascular tone of the hemodynamic system and a computer.
  • the device for determining the volemic status and / or the vascular tone of the hemodynamic system and a ventilator can also be part of a system according to the invention or constitute this system.
  • the invention also relates to a computer program, comprising instructions which, when the program is executed by a computer, cause the computer to execute the method.
  • the invention also relates to a computer readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the method.
  • the technology according to the invention is related to Photo-Plethysmo-Graphy (PPG), as it is used in commercially available pulse oximeters, such as. B. in typical transmission pulse oximeters for fingers, is common.
  • PPG wave corresponds to the absorption of light by tissue on the finger according to the Beer-Lambert law.
  • the absorbed signal is based on two parts: a pulsatile component (AC), which represents the pulse pressure wave, and a non-pulsatile component (DC), which represents venous blood, nails, bones, skin, and soft tissue.
  • AC pulsatile component
  • DC non-pulsatile component
  • the main differences between the PPG technology required according to the invention and standard pulse oximeters are:
  • AC and DC data are available at least on a beat-by-beat basis
  • PPG represents the non-invasive FLOW pulse wave (similar to the PRESSURE pulse wave, which is obtained through an intra-arterial catheter).
  • the shape of the PPG - i.e. defined by the amplitude, width and the position of the dichrotic notch in the AC component - is related to the changes in arterial blood pressure caused by the change in vascular tone.
  • the PPG can detect arterial hypertension and hypotension caused by vasoconstriction / vasodilation with high sensitivity and specificity (97.8% and 98.4%, respectively).
  • the novelty of this approach is its unique ability to monitor vascular tone; a non-invasive diagnostic capability previously only available by invasive means in patients receiving advanced hemodynamic monitoring to calculate systemic vascular resistance.
  • Our PPG waveform analysis offers an unprecedented non-invasive way of deriving beat-to-beat information about the vascular tone at the bedside.
  • the DC component is influenced by two components:
  • any change in the DC component is caused by changes in the volume of venous blood on the finger (the dynamic path). According to our measurements on patients, these changes are associated with changes in the volume state. Therefore, the DC component should be used both in the operating room and in the intensive care unit to diagnose and monitor the volemia or preload dependency of a patient.
  • the combined monitoring of both the AC and DC components provides clinically relevant information about changes in vascular tone and volemic status.
  • various causes such as vasoconstriction, normal vascular tone, vasodilation, hypovolemia, normovolemia and hypervolemia and thus the physiopathological mechanisms of arterial blood hyper- and hypotension can be identified.
  • This type of monitoring is highly innovative as it is completely non-invasive and in real time.
  • the technology is based on the idea that the DC signal can be used to detect the preload dependency or fluid response in critically ill patients in the context of a DYNAMIC maneuver such as increasing PEEP, maneuvering to raise the legs, etc.
  • a computer can be understood to be any computing device which is used to interact with one of the measuring devices for measuring data from is intended for a living being.
  • a computer can be understood as a chip or control unit of a ventilator or a pulse oximeter that can be at least indirectly connected to a ventilator.
  • the computer can consist of a chip or the control unit of a ventilator or of at least one chip or the control unit of a pulse oximeter that can be at least indirectly connected to a ventilator.
  • a computer can be designed as a chip or control unit of a device for determining the volemic status and / or as a chip or control unit of a device for determining the vascular tone of the hemodynamic system.
  • waveforms are signal curves that are recorded by the device for determining the volemic status and / or the vascular tone of the hemodynamic system, in particular a photoplethysmography (PPG) signal or light absorption or an AC signal or a DC signal .
  • PPG photoplethysmography
  • a ventilator is to be understood as any device that supports a user or patient in natural breathing, takes over the ventilation of the user or living being (e.g. patient and / or newborn and / or premature baby) and / or is used for respiratory therapy and / or in some other way affects the breathing of the user or patient.
  • Ventilators can also be understood as diagnostic devices for ventilation. Diagnostic devices can generally be used to record medical and / or respiratory parameters of a living being. This also includes devices which can record and optionally process medical parameters of patients in combination with breathing or exclusively relating to breathing.
  • FIG. 1 shows the method according to the invention for determining the volemic status and / or the vascular tone of the hemodynamic system and the device for determining the volemic status and / or the vascular tone of the hemodynamic system.
  • a photoplethysmography (PPG) signal 11 is generated and recorded by one or more of the following devices 1; a photoplethysmograph, a pulse oximeter, a transmission optical sensor, a reflective photo-optical sensor, a pressure transducer, a tonometry device, a strain gauge, an ultrasound device, an electrical impedance measuring device, a blood pressure monitor, an EKG device and a camera / detector system.
  • the aforementioned devices can be part of a medical ventilator or be connected to a medical ventilator.
  • the device for determining the volemic status and / or the vascular tone of the hemodynamic system and a ventilator can also be part of a system according to the invention or constitute this system.
  • the device 1 for determining the volemic status and / or the vascular tone of the hemodynamic system comprises a sensor 9 with a light emitter 2 and a light detector 3 modulated light with the detector 3.
  • a computer 7 determines a from the signal of the detector 3 Photoplethysmography (PPG) signal 11.
  • a light source 2 emits light onto a living tissue 10 (such as, for example, fingers, forehead or the like) and a detector S receives at least part of the light modulated by the tissue.
  • the modulated light can be or comprise transmitted and / or reflected and / or refracted light.
  • Various electronic components 4, 5, 6, which process the signal for the computer 7, can be connected downstream of the detector.
  • the computer is set up and designed to carry out the following steps: Determination of a plurality of PPG signals over time by the computer 7 from the living tissue;
  • the computer analyzes the photoplethysmography (PPG) signal using the first or second derivative (d2DVP / dt2) of the PPG.
  • the computer analyzes the signal of photoplethysmography (PPG) using artificial neural networks, the extraction of periodic components using frequency analysis or non-linear dynamic analysis.
  • PPG photoplethysmography
  • Determining a pulse rate from the AC component includes:
  • Determining a pulse strength metric from the AC component comprises: the computer 7 identifying a plurality of signal peaks within the AC component; and identifying an amplitude for each of the plurality of signal peaks by the computer 7.
  • the computer 7 is also configured to record hemodynamic standard parameters from other sensors 20, 30 for a global assessment of the hemodynamics.
  • the computer 7 is further configured to check the predicted volemia by including hemodynamic parameters such as the non-invasive arterial blood pressure signal from other sensors 20, 30.
  • the computer 7 is further configured to check the predicted vascular tone by including hemodynamic parameters from other sensors 20, 30.
  • the computer 7 is also configured to emit light.
  • the computer 7 is further configured to determine blood oxygen saturation from the PPG signal.
  • veins, capillaries, bones and other tissue components absorb incident light relatively constantly - as a measured value, it can be viewed as a pure direct current signal (DC) 13 over the duration of a single heartbeat.
  • DC direct current signal
  • arterial blood absorbs the light to different degrees - due to the pulsating change in volume within a heartbeat - which results in an alternating current signal (AC) 12 in addition to the DC signal that is also present.
  • AC alternating current signal
  • Figure 2a shows a cross-sectional diagram of an artery and vein during systole and diastole, illustrating the non-pulsating (DC) 13 and pulsating (AC) 12 sections of arteries and the relative lack of volume changes in veins and capillaries.
  • DC non-pulsating
  • AC pulsating
  • DC non-pulsating
  • AC pulsating
  • DC non-pulsating
  • AC pulsating
  • the device 1 for determining the volemic status and / or the vascular tone of the hemodynamic system therefore comprises a sensor 9 with a light emitter 2 and a light detector 3.
  • the sensor illuminates (light emitter 2) living tissue 10 with light of specific wavelengths and receives it Light modulated by the tissue 10 with the detector 3.
  • a computer 7 determines a photoplethysmography (PPG) signal 11 or a light absorption from the signal from the detector 3.
  • PPG photoplethysmography
  • Various electronic components 4, 5, 6, which process the signal for the computer 7, can be connected downstream of the detector.
  • the computer is set up and designed to carry out the following steps; Determination of an AC component 12 from the PPG signal or the light absorption. Determination of a DC component 13 from the PPG signal or the light absorption.
  • the computer 7 is set up and designed to carry out the following method steps:
  • FIG. 2b shows the PPG amplitude in% over time for the pulsating (AC) 12 component.
  • the curve of the PPG wave has two maxima which are separated by an indentation.
  • the indentation represents the dicrotic notch 14.
  • the first wave S is based on the systolic (forward) wave and the second wave is based on the diastolic (backward) wave.
  • the device 1 for determining the volemic status and / or the vascular tone of the hemodynamic system therefore comprises a sensor 9 with a light emitter 2 and a light detector 3.
  • the sensor illuminates (light emitter 2) living tissue 10 with light of certain wavelengths and receives from it Tissue 10 modulated light with the detector 3.
  • a computer 7 determines a photoplethysmography (PPG) signal 11 from the signal of the detector 3.
  • a light source 2 emits light onto a living tissue 10 (such as fingers, forehead or the like) and a detector 3 receives at least part of the light modulated by the tissue.
  • the modulated light can be or comprise transmitted and / or reflected and / or refracted light.
  • Various electronic components 4, 5, 6, which process the signal for the computer 7, can be connected downstream of the detector.
  • the computer is set up and designed to carry out the following steps: determining a multiplicity of AC components 12 of the PPG signals determining a multiplicity of DC components 13 of the PPG signals.
  • the computer 7 is set up and designed to carry out the following method steps:
  • the computer is also set up and designed to determine a percentage PPG amplitude from the AC component.
  • the computer is also set up and designed to analyze the curve of the PPG wave for maxima, in particular to identify two maxima which are separated by an indentation, the indentation representing the dicrotic notch 14.
  • the computer is set up and designed to identify a first maximum S based on the systolic (forward) wave and to identify a second maximum D based on the diastolic (backward) wave.
  • the computer is set up and designed to determine the time delay (DT) between the maxima S and D.
  • the time delay between maxima depends on the stiffness of the arteries.
  • the computer is set up and designed to determine a measure for the stiffness of the arteries from the time delay (DT) between the maxima S and D.
  • the computer is set up and designed to determine an amplitude of the first maximum S and an amplitude of the second maximum D.
  • the ratio of the amplitude of the first maximum S to the amplitude of the second maximum D is related to the systemic vascular resistance.
  • the computer is therefore set up and designed to determine a measure for the systemic vascular resistance from the ratio of the amplitude of the first maximum S to the amplitude of the second maximum D.
  • FIGS. 3a and 3b show the waveforms according to FIG. 2b with different dicrotic notches 14.
  • FIGS. 3a and 3b show the PPG amplitude in% over time for the pulsating (AC) 12 component.
  • the curve of the PPG wave has two maxima which are separated by an indentation 14.
  • the indentation represents the dicrotic notch 14.
  • the dicrotic notch 14 is below 50% of the maximum PPG amplitude.
  • Figure 3b the dicrotic notch 14 is over 50% of the maximum PPG amplitude.
  • the device 1 for determining the volemic status and / or the vascular tone of the hemodynamic system here comprises a sensor 9 with a light emitter 2 and a light detector 3.
  • the sensor illuminates (light emitter 2) living tissue 10 with light of certain wavelengths and receives from it Tissue 10 modulated light with the detector 3.
  • a computer 7 determines a photoplethysmography (PPG) signal 11 from the signal of the detector 3.
  • PPG photoplethysmography
  • a light source 2 emits light onto a living tissue 10 (such as fingers, forehead or the like) and a detector 3 receives at least part of the light modulated by the tissue.
  • the modulated light can be or comprise transmitted and / or reflected and / or refracted light.
  • the computer 7 is set up and designed to carry out the following method steps:
  • Determine a variety of AC components of the PPG signals Determining a plurality of DC components of the PPG signals, determining a plurality of AC waveforms from the AC components and identifying differences in the AC waveforms over time by comparing at least two AC waveforms;
  • the computer is also set up and designed to determine a percentage PPG amplitude.
  • the computer is also set up and designed to determine a maximum percentage PPG amplitude, which is equal to 100%, and to determine submaximal percentage PPG amplitudes.
  • the computer is also set up and designed to analyze the curve of the PPG wave for maxima and in particular to identify two maxima which are separated by an indentation 14, the indentation representing the dicrotic notch 14.
  • the computer is set up and designed to identify a first maximum S, based on the systolic (forward) wave, and to identify a second maximum D, based on the diastolic (backward) wave, and to assign a dicrotic notch 14 between the maxima identify.
  • the computer is also set up and designed to determine a maximum percentage PPG amplitude and submaximal percentage PPG amplitudes in the range of below or above 50%.
  • Figure 4 shows normal PPG waveforms (middle) and PPG waveforms typical of vasoconstriction (left half) or PPG waveforms typical of vasodilation (right half). It is noticeable that the dicrotic notch 14 only occurs in the normal PPG waveform and in the PPG waveform in the case of vasodilation. The dicrotic notch may not be detectable during vasoconstriction.
  • the device according to the invention for determining the volemic status and / or the vascular tone of the hemodynamic system comprises a computer 7 for receiving a photoplethysmography (PPG) signal 11 that sends an alternating AC 12 component and a DC 13 component from a sensor 2, 3 , 9 in data communication with a living tissue 10 contains.
  • PPG photoplethysmography
  • the device is set up, for example, to determine a multiplicity of PPG signals over time by the computer 7 from the living tissue.
  • the device is set up, for example, for determining a multiplicity of AC components of the PPG signals by the computer 7 and for determining a multiplicity of DC components of the PPG signals by the computer 7.
  • the computer 7 is set up and designed to carry out the following method steps:
  • the computer is also set up and designed to determine a percentage PPG amplitude or the course of a PPG signal.
  • the computer is also set up and designed to analyze the course of the PPG signal for maxima and in particular to identify two maxima which are separated by an indentation 14, the indentation representing the dicrotic notch 14.
  • the computer is, for example, set up and designed to identify a first maximum S based on the systolic (forward) wave and to identify a second maximum D based on the diastolic (backward) wave and a dicrotic notch 14 between the maxima to identify.
  • the computer is also set up and designed to determine a vasoconstriction if no dicrotic notch 14 can be identified from the course of the PPG signal.
  • the computer is also set up and designed to determine a vasodilation if a dicrotic notch 14 can be identified from the course of the PPG signal.
  • the device is set up, for example, to verify a vasoconstriction by determining the blood pressure, a vasoconstriction being identified if the course of the PPG signal does not have a dicrotic notch 14 and the blood pressure also rises.
  • the device is set up, for example, to verify vasodilation by determining the blood pressure, with vasodilation being identified when the course of the PPG signal has a dicrotic notch 14 and the blood pressure also falls.
  • the device is set up, for example, to classify the vascular tone on the basis of the photo-plethysmography waveform.
  • the classification is based on the amplitude of the photoplethysmography (PPG) (Fig. 4) and on the positioning of the dicrotic notch Fig. 3.
  • the device is designed to identify normal form of PPG and vasodilation and vasoconstriction:
  • the device is set up to identify a normal PPG shape when the dicrotic notch 14 is between 20 and 55%, preferably 30-50% of the total PPG amplitude.
  • Vasodilation increases the PPG amplitude as the tissue has more blood flow (more infrared light absorption). With slight vasodilation, the notch 14 reaches the baseline 15, although the backward wave is still evident. With pronounced vasodilation, notch 14 is absent, and with very pronounced vasodilation, the notch becomes negative (goes below baseline 15).
  • the vasoconstriction (Fig. 4 left) shows less PPG amplitude than normal, which means that blood flow is decreasing (less infrared light absorption).
  • the notch 14 rises to over 50% of the total PPG amplitude and / merges with the systolic pulse peak.
  • the device according to the invention for determining the volemic status and / or the vascular tone of the hemodynamic system comprises a computer 7 for receiving a photoplethysmography (PPG) signal 11 that sends at least one DC 13 component from a sensor 2, 3, 9 in data communication a living tissue 10 contains.
  • PPG photoplethysmography
  • the computer 7 is set up and designed to carry out the following method steps:
  • the device is set up, for example, to determine a DC 13 signal over time by the computer 7 from the living tissue.
  • the device is also set up to define the course of a DC 13 signal (over time) as the baseline 13b, with the baseline 13b essentially not changing the DC signal over time (for at least 10 seconds, preferably for at least 30 seconds) having.
  • the device is also set up to determine a deviation from the baseline 13b from the course of a DC 13 signal (over time).
  • a fall in the DC signal below the baseline 13b is assessed as hypovolemia if the fall in the DC signal below the baseline 13b lasts for at least 10 seconds, preferably for at least 30 seconds or longer.
  • a rise in the DC signal above the baseline 13b is assessed as hypervolaemia if the rise in the DC signal above the baseline 13b lasts for at least 10 seconds, preferably for at least 30 seconds or longer.
  • An increase in the DC signal to a stored baseline 13b is assessed as a normovolemia if the increase in the DC signal to the baseline 13b occurs when hypovolemia has previously been identified that lasts for at least 10 seconds, preferably for at least 30 seconds or lasted longer and then an increase in the DC signal was identified.
  • FIGS. 6 and 7 illustrate the calibration 14 of the PPG measurement for the volemia determination.
  • the patient must first hold the hand or arm with the PPG sensor on one level with the heart while lying down so that the PPG basic signal 15 can be determined at an angle of 0 °.
  • the basic PPG signal 15 is stored in the device.
  • the hand is then raised at a 45 ° angle to simulate vasodilation and hypovolemia.
  • a determination of the PPG signal for vasodilation and hypovolemia 16 is carried out.
  • the PPG signal representing vasodilation and hypovolemia 16 is stored in the device.
  • the PPG basic signal 15 is then determined again.
  • the hand is then lowered by 45 °, as a result of which blood flows into the hand in order to simulate vasoconstriction and hypervolemia.
  • a determination of the PPG signal for vasoconstriction and hypervolaemia 17 is carried out.
  • the PPG signal representing vasoconstriction and hypervolemia 17 is stored in the device.
  • the PPG basic signal 15 is then determined again.
  • the device then monitors the volemia status and / or the vasoconstriction or vasodilation by determining 18 the PPG signal, in particular the DC component, over time.
  • the device according to the invention for determining the volemic status and / or the vascular tone of the hemodynamic system includes a computer 7 for receiving a photoplethysmography (PPG) signal, the at least one DC signal component from a sensor 2, 3, 9 in data communication with a living tissue 10 contains.
  • PPG photoplethysmography
  • the device is set up, for example, to determine a DC signal over time by the computer 7 from the living tissue.
  • the computer 7 is set up and designed to carry out the following method steps:
  • the device is also set up to define the course of a DC signal (over time) as the basic signal 15, with the basic signal 15 essentially not changing the DC signal over time (for at least 10 seconds, preferably for at least 30 seconds) having.
  • the device is also set up to determine a deviation from the basic signal 15 from the course of a DC signal (over time).
  • a fall in the DC signal below the basic signal 15 is assessed as hypovolemia if the fall in the DC signal below the basic signal 15 lasts for at least 10 seconds, preferably for at least 30 seconds or longer.
  • a rise in the DC signal above the basic signal 15 is assessed as hypervolaemia if the rise in the DC signal above the basic signal 15 lasts for at least 10 seconds, preferably for at least 30 seconds or longer.
  • the comparison of the exemplary embodiments in FIGS. 5, 6 and 7 shows that the base line 13b can essentially correspond to the basic signal 15.
  • 8 shows a PPG measurement according to the invention for determining the volume and / or determining a vasoconstriction or vasodilation with the device according to the invention.
  • the calibration according to FIGS. 6, 7 defines a range of the AC signal which corresponds to the normal vascular tone 21.
  • the inventive device and the method are set up and designed for receiving a photoplethysmography (PPG) signal 11 by a computer 7, which has an alternating AC-12 component as the PPG amplitude and the DC-13 component as the PPG baseline a sensor 2, 3, 9 in data communication with a living tissue 10;
  • PPG photoplethysmography
  • the computer 7 is set up and designed to carry out the following method steps:
  • the calibration according to FIGS. 6, 7 defines a range of the DC signal which corresponds to a normal volemia 24.
  • the inventive device and the method are set up and designed for receiving a photoplethysmography (PPG) signal 11 by a computer 7, which has an alternating AC-12 component as the PPG amplitude and the DC-13 component as the PPG baseline a sensor 2, 3, 9 in data communication with a living tissue 10; Determining a plurality of PPG signals by the computer 7 from the living tissue;
  • PPG photoplethysmography
  • the inventive device and the method are set up and designed for receiving a photoplethysmography (PPG) signal 11 by a computer 7, which has an alternating AC-12 component as the PPG amplitude and the DC-13 component as the PPG baseline a sensor 2, 3, 9 in data communication with a living tissue 10;
  • PPG photoplethysmography

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Abstract

L'invention concerne un procédé et un dispositif de détermination de l'état volémique et du tonus vasculaire du système hémodynamique, le procédé comprenant : la réception d'un signal de photopléthysmographie (PPG) au moyen d'un ordinateur, lequel signal comprend une composante alternative alternative en tant qu'amplitude de PPG et la composante continue en tant que ligne de base de PPG à partir d'un capteur en communication de données avec un tissu vivant; la détermination d'une multiplicité de signaux de PPG au moyen de l'ordinateur à partir du tissu vivant; la détermination d'une multiplicité de composantes alternatives des signaux de PPG au moyen de l'ordinateur, la détermination d'une multiplicité de composantes continues des signaux de PPG au moyen de l'ordinateur, la détermination d'une multiplicité de formes d'onde CA à partir des composantes alternatives au moyen de l'ordinateur et l'identification des différences dans les formes d'onde CA dans le temps par comparaison d'au moins deux formes d'onde CA; la détermination d'une tendance de signal CC dans le temps au moyen de l'ordinateur par comparaison d'au moins deux composantes continues; et la détermination de l'état volémique et/ou du tonus vasculaire du système hémodynamique du tissu vivant au moyen de l'ordinateur en tant que réaction à au moins une différence de forme d'onde CA et/ou une tendance de signal CC dans le temps.
EP21719051.1A 2020-04-08 2021-04-08 Procédé et dispositif de détermination de l'état volémique et du tonus vasculaire Pending EP4132352A1 (fr)

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US7785262B2 (en) * 2005-04-25 2010-08-31 University Of Florida Research Foundation, Inc. Method and apparatus for diagnosing respiratory disorders and determining the degree of exacerbations
US8905939B2 (en) * 2006-07-13 2014-12-09 Edwards Lifesciences Corporation Method and apparatus for continuous assessment of a cardiovascular parameter using the arterial pulse pressure propagation time and waveform
US9782090B1 (en) * 2007-03-30 2017-10-10 David G Silverman Method and system enabling photoplethysmograph measurement of volume status
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US9113830B2 (en) * 2011-05-31 2015-08-25 Nellcor Puritan Bennett Ireland Systems and methods for detecting and monitoring arrhythmias using the PPG
US20130172759A1 (en) * 2011-08-08 2013-07-04 Richard J. Melker Systems And Methods For Using Photoplethysmography In The Administration Of Narcotic Reversal Agents
US9522317B2 (en) * 2011-08-19 2016-12-20 Pulson, Inc. Systems and methods for coordinating musculoskeletal and cardiovascular or cerebrovascular hemodynamics
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