EP2836112A1 - Procédé et dispositif pour la surveillance à long terme de la rigidité artérielle et de la calcification des vaisseaux sanguins d'un patient - Google Patents

Procédé et dispositif pour la surveillance à long terme de la rigidité artérielle et de la calcification des vaisseaux sanguins d'un patient

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Publication number
EP2836112A1
EP2836112A1 EP13718111.1A EP13718111A EP2836112A1 EP 2836112 A1 EP2836112 A1 EP 2836112A1 EP 13718111 A EP13718111 A EP 13718111A EP 2836112 A1 EP2836112 A1 EP 2836112A1
Authority
EP
European Patent Office
Prior art keywords
patient
pressure
particular patient
measuring
pulse wave
Prior art date
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.)
Withdrawn
Application number
EP13718111.1A
Other languages
German (de)
English (en)
Inventor
Wei Zhang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland 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 Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP2836112A1 publication Critical patent/EP2836112A1/fr
Withdrawn legal-status Critical Current

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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
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • 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
    • A61B5/02125—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics of pulse wave propagation time
    • 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
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • A61B5/02225—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers using the oscillometric method

Definitions

  • the invention relates to the field of monitoring the circulatory stability of patients, especially those patients who are regularly dependent on extracorporeal blood treatment.
  • a new method and a new device for determining at least one parameter for the arterial vascular stiffness and vascularization during a plurality of blood treatment sessions and storing at least one value of the parameter per blood treatment session to produce a long-term trend of the at least one characteristic are proposed.
  • the new method and apparatus also allow continuous measurement of blood pressure.
  • the known blood treatment devices include, for example, the devices for hemodialysis, hemofiltration and hemodiafiltration.
  • the blood in an extracorporeal bloodstream flows through a blood treatment unit, e.g. a dialyzer.
  • a blood treatment unit e.g. a dialyzer.
  • Monitoring the circulatory stability of patients' blood circulation during extracorporeal blood treatment is a constant challenge for the staff of a dialysis clinic.
  • An important aspect is the early detection of short-term hypotensive episodes during an extracorporeal blood treatment session.
  • the prior art discloses various methods and apparatus for monitoring the patient's blood pressure and pulse rate during a blood treatment session.
  • BPM Band Pressure Monitor
  • the module BPM also makes it possible to carry out automatic measurements at predetermined time intervals during a blood treatment session.
  • the module BPM is used for example as a component of the hemodialysis machines of the applicant Fresenius Medical Care Germany GmbH from the model series 4008 and 5008, wherein the measurement results can be recorded on the associated with the hemodialysis machine electronic data carriers.
  • Such a method and such a device are described for example in the document DE 10 2006 010 813 AI the applicant.
  • the module BPM provides for the application of a conventional pressure measuring cuff on the patient's upper arm, so that in practice measurements are carried out discontinuously at intervals of about one hour.
  • the module BPM is therefore less suitable in the known embodiment with conventional pressure measuring cuff.
  • PWV pulse wave velocity
  • PTT pulse transit time
  • Measurements of the type mentioned above relate to the observation period of a blood treatment session, for example, about four to five hours, and serve primarily patient safety during each dialysis treatment. The measurement data are then not further evaluated and deleted because the monitoring task is completed at the end of the treatment.
  • the attending physician has several other health-related parameters to consider.
  • the risk assessment of possible pathological vascular changes for example an arterial vascular calcification or atherosclerosis
  • Selected parameters of the current state of the stiffness or elasticity of the arterial vascular system can be determined by the attending physician, for example with the method described in the document WO 2005/077265 AI of the Applicant Illyes and Beres.
  • parameters for the rigidity or elasticity of the arterial vascular system for example, the so-called “Augmentation Index (AIx)" and the so-called “Ejection Duration Index (ED)" are determined by means of this method.
  • a corresponding medical measuring and computing unit is marketed under the trade name Arteriograph by Arteriomed GmbH, Germany.
  • the document WO 2005/077265 AI also describes a method for oscillometric blood pressure measurement on the basis of a conventional blood pressure measuring cuff on the upper arm of the patient.
  • the present invention
  • a parameter is understood to mean a variable describing the vascular stiffness of a specific patient or the change thereof.
  • the parameter may be a dimensioned or dimensionless amount.
  • the vascular stiffness of a patient may change due to vascular calcification.
  • a further object of the present invention is to specify a method and a measuring and calculating unit for the long-term monitoring of the arterial vascular stiffness of a specific patient.
  • Another object of the present invention is to provide an extracorporeal blood treatment device having an integrated measurement and processing unit configured to enable long-term monitoring of the arterial vascular stiffness of a particular patient.
  • a further object of the present invention is to provide a measuring and calculating unit for the long-term monitoring of the arterial vascular stiffness of a patient, which requires no further sensor technology apart from a conventional non-invasive blood pressure measurement on the patient.
  • Another object of the present invention is to provide a method and a measuring and calculating unit for monitoring the circulatory stability of a patient, which in addition to the short-term continuous automatic monitoring of the blood pressure during a blood treatment session, also a long-term monitoring of the arterial Vascular stiffness of the particular patient allows without the need for additional equipment.
  • Another object of the present invention is to provide a method and a measuring and calculating unit for long-term monitoring of the arterial vascular stiffness of a particular patient, which is particularly cost-effective.
  • Another object of the present invention is to provide a method and a measuring and calculating unit for the long-term monitoring of the arterial vascular stiffness of a particular patient, which is particularly user-friendly.
  • An object of the present invention is to provide a method and a measuring and calculating unit for the long-term monitoring of the arterial vascular stiffness of a particular patient, which is provided by an additional hardware component, e.g. an additional electronic board, and a software update in the known module for blood pressure monitoring (BPM) of the Applicant Fresenius Medical Care Germany GmbH can be implemented.
  • an additional hardware component e.g. an additional electronic board
  • BPM blood pressure monitoring
  • these objects are achieved by an oscillometric evaluation of at least one caused by cardiac contraction pressure pulse wave as a function of time.
  • the desired characteristic for the arterial stiffness of a particular patient from the shape or the course of at least one caused by cardiac contraction pressure pulse wave of the particular Patients are determined as a function of time assuming a constant length of the descending aorta of the particular patient.
  • the measurement of the at least one pressure pulse wave caused by cardiac contraction is particularly preferably carried out by means of a pressure sensor on the patient. It is also possible to measure the so-called heart volume pulse or by means of an ultrasound measurement the so-called blood flow pulse by means of an optical sensor and to evaluate it according to the invention.
  • the evaluation of the shape or the course of at least one caused by cardiac contraction pressure pulse wave of the particular patient as a function of time include determining the time of the systolic maximum and determining the time of a time occurring after the systolic maximum further local pulse event, which occurs due to the pressure pulse wave of the selected heartbeat reflected at the aortic bifurcation of the patient.
  • the local pulse event occurring after the systolic maximum over time may be a local maximum or a local inflection point. From the difference in time of the local pulse event due to the pressure pulse wave of the selected heartbeat reflected at the aortic bifurcation of the patient and the time of the systolic maximum of the selected heartbeat, the pulse travel time in the descending aorta of the patient can be calculated as a measure of arterial vascular stiffness. Knowing the length of the descending aorta of the particular patient, the pulse wave velocity can be calculated as a further measure of arterial vascular stiffness.
  • the trend of the pulse wave transit time can be evaluated.
  • the length of the descending aorta of the particular patient is assumed to be constant, without its amount having to be known. Only the pulse wave transit time trend of the particular patient may indicate whether the arterial vessel stiffness trend is consistent, increasing or decreasing.
  • an indication is to be obtained as to whether the arterial vascular stiffness of the particular patient is the age of the particular patient or is increased or even critically elevated, then this is only possible knowing the length of the descending aorta of the particular patient Comparison with empirical values is possible.
  • the detected pulse wave velocity is inversely proportional to the pulse wave transit time if the length of the descending aorta of the same patient is assumed to be constant.
  • the pulse wave velocity in the descending aorta of the particular patient is particularly suitable, which according to the invention from the shape or the course of at least one caused by cardiac contraction pressure pulse wave as a function of time and for the particular patient in absolute terms determined length of the descending aorta of the patient can be determined.
  • the comparison of the measured pulse wave velocity with empirical values may provide an indication as to whether the arterial vascular stiffness of the particular patient is equal to or greater than, or even critically elevated, the age of the particular patient.
  • the length of the descending aorta can be determined individually for each patient, that is, the length of the descending aorta can vary in length for different patients.
  • the length of the descending aorta of a patient according to the invention can be determined in a simple manner non-invasively with sufficient accuracy.
  • the present invention reverses the conventional approach that assumes constant vascular stiffness during the observation period and makes the new assumption that in the observation period extended to a plurality or a plurality of blood treatment sessions, only the length of the descending aorta is considered constant for a given patient may be variable and the arterial vascular stiffness may be variable. This opens the way to calculate over a long period in successive time intervals recorded, comparable among each other characteristics for the arterial vascular stiffness of a patient and to determine trends, always using the same value for the length of the descending aorta the recurrent calculations of the characteristic of arterial vascular stiffness is placed.
  • the course of at least one pressure pulse wave as a function of time caused by cardiac contraction can be carried out particularly advantageously according to the present invention by piezoelectric measurement of the blood pressure on the patient's wrist or by means of a conventional blood pressure cuff on the patient's upper arm.
  • the method according to the invention and the device according to the invention particularly advantageously enable long-term monitoring of the arterial vascular stiffness for the risk assessment of patients who are dependent on extracorporeal blood treatment, because in such patients the blood pressure can be measured continuously during the regular blood treatment sessions and measurement data thereby obtained which can additionally be evaluated according to the invention. From the characteristic of the arterial vascular stiffness it can be concluded on the extent of vascular calcification.
  • the device according to the invention and the method according to the invention can provide the attending physician with important information for the patient-specific optimization of the patient Provide extracorporeal blood treatment therapy, for example, for a targeted adjustment of the Ca concentration of the dialysis fluids used.
  • the quality of the extracorporeal blood treatment therapy can be further improved by the present invention.
  • the present invention and method provide the clinician with important guidance for monitoring and optimizing a medication therapy accompanying the blood treatment, e.g. against hypocalcemia, in particular with the administration of vitamin D supplements against calcitriol deficiency.
  • the patient safety can be further improved.
  • a hemodialysis patient undergoing end stage renal disease undergoes hemodialysis treatment for several to three hours per week for several to several hours, for several or many years.
  • a long-term period is understood in the present invention to mean, for example, a period of several, several or many weeks, months or years.
  • a long-term period includes substantially a plurality or a plurality of blood treatment sessions.
  • the at least one characteristic for the characterization of the arterial vascular stiffness during a plurality or a plurality of blood treatment sessions can be determined and the value of the at least one characteristic for the characterization of the arterial vascular stiffness can be stored on an electronic data carrier.
  • additional data such as systolic blood pressure and / or diastolic blood pressure and / or heart rate, may be stored on an electronic data carrier after the blood treatment sessions in addition to the at least one arterial stiffness characterization parameter.
  • the historical values of the at least one historical parameter already stored may form a time series that is updated with each new value of the characteristic.
  • the inventive apparatus and method may include a statistical evaluation of the historical values of the at least one characteristic.
  • Statistical evaluation is a trend in particularly preferred embodiments.
  • the trend can be graphically processed in particularly preferred embodiments of the present invention, for example in the form of a curve in a diagram and / or as a warning on the screen or touch screen of the extracorporeal blood treatment device or as a measurement record of a connected printer.
  • the trend may serve as a basis for the physician to make a diagnosis regarding the development of arterial vascular stiffness and vascular calcification.
  • the electronic data carrier on which the at least one value of a parameter for characterizing the arterial vascular stiffness can be stored is an individual electronic patient card of the particular patient.
  • the electronic patient card has an electronic data storage suitable and configured for read and write access.
  • the particular advantage of the patient card is that the data can be carried centrally by the patient, regardless of the blood treatment device used and the hospital visited.
  • patient-specific information which is used to calculate the at least one parameter for characterizing the arterial vascular stiffness can be stored centrally on the patient card. Thus, these data can be used if the at least one parameter for the characterization of the arterial vascular stiffness is calculated.
  • the term electronic patient card includes any suitable mobile electronic data carrier uniquely associated with or attributable to a particular patient on which the recorded historical values of the at least one characteristic can be stored independently of the extracorporeal blood treatment device. These include, for example, SD card, memory card, memory stick, USB device and other known to those skilled electronic data carrier.
  • the electronic data carrier is an electronic patient card with data memory in credit card format, on which the personal data of the patient can be stored and the patient due to the practical format together with other documents of the same format (identity card, ID card, driving license etc .) can always carry with you without additional effort.
  • an extracorporeal blood treatment device for example a hemodialysis device
  • an extracorporeal blood treatment apparatus for example a hemodialysis apparatus, has a measuring and calculating unit according to the invention configured such that the statistical evaluation of the at least one characteristic of the arterial vascular stiffness determined during the extracorporeal blood treatment is a trend and / or displayed as a warning on the screen of the extracorporeal blood treatment device.
  • a further aspect of the invention provides that the at least one parameter for characterizing the arterial vascular stiffness is stored in the memory of the control and computing unit of the blood treatment machine and unambiguously assigned to the patient. This makes it possible, even without the use of the patient card, the characteristic for Store characterization of the arterial vascular stiffness so that it is still available in the event of loss or damage to the patient card.
  • a further aspect of the present invention provides that the control and processing unit of the blood treatment machine is configured such that the patient-specific data stored in the memory of the control and processing unit of the blood treatment machine are stored on a new patient card in the event of loss or damage of the patient card can.
  • a further aspect of the present invention provides that the control and processing unit of the blood treatment machine is configured such that the patient-specific data stored in the memory of the control and processing unit of the blood treatment machine can be stored on at least one computer when the dialysis machine is networked in a computer network.
  • the method and the measuring and calculating device according to the present invention are suitable for the long-term monitoring of arterial vascular stiffness and vascular calcification of a patient.
  • the application of the method according to the invention and the device according to the invention is therefore not limited to dialysis patients and is also suitable for healthy persons in the context of prevention.
  • the teaching of the present invention also covers the case that the method according to the invention and the device according to the invention can be used independently of extracorporeal blood treatment sessions.
  • Figure 1 is a schematic representation of the descending aorta of a human with the branching arteries and a pressure measuring point on the wrist of humans and a pressure measuring cuff on the upper arm of man.
  • Figure 2 is an exemplary diagram of the time course of a
  • Figure 3 is a schematic representation of the measuring and
  • Figure 4 is a schematic representation of the measuring and
  • Arithmetic unit of Figure 3 in conjunction with an extracorporeal blood treatment machine (the extracorporeal blood circulation is not shown).
  • FIG. 5 shows a schematic representation of an exemplary trend of a characteristic variable of the arterial vessel stiffness on the screen display of the measuring and calculating unit according to the invention from FIG. 3 or FIG. 4.
  • Figure 1 shows in a simplified schematic representation the descending aorta 5 of a human patient with the largest branching arteries, namely the brachial artery 3, the renal and hepatic arteries and the lliac arteries.
  • the entire descending aorta 5 has in the schematic representation of the length L 2 , as the distance between the aortic arch tip of the aortic arch 2 and the aortic bifurcation 7 is defined.
  • the aortic arch 2 with the length Lo is shown schematically.
  • the aortic arch 2 with the length Lo is shown schematically.
  • brachial artery 3 branches off the brachial artery 3, which merges into the radial artery 4 in the arm of the patient.
  • the brachial artery 3 and radial artery 4 have in the schematic representation together the length Li.
  • a pressure measuring point 12 is shown, to which a non-invasive pressure sensor, for example on the wrist of the patient, can be attached.
  • a non-invasive pressure sensor for example on the wrist of the patient.
  • an optional pressure measuring point 12a for a conventional pressure measuring cuff is shown.
  • a first branching point 6 to the renal and hepatic arteries and a second branching point the aortic bifurcation 7 are shown.
  • the first branching point 6 acts as a first reflection part and the aortic bifurcation 7 acts as a second reflection point for the cardiac pressure pulse wave coming from the heart 1 of the patient.
  • reflected pressure pulse waves traverse the descending aorta 5 in the opposite direction of advancement to the cardiac pressure pulse waves.
  • the reflected pressure pulse waves are superimposed in the aortic arch 2 at the branching to the brachial artery
  • pressure pulse waves can be measured, which show a characteristic shape due to the superposition of heart pressure pulse waves and reflected pressure pulse waves.
  • the progress directions of the pressure pulse waves are indicated by arrows. 2 shows a schematic representation of an example measured at the pressure measuring point 12 of Figure 1 pressure pulse course as a function of time.
  • t 3 410 ms, which occurs due to the diastolic pressure pulse wave.
  • a local maximum occurs and occurs in about 10% of the measurements as a local pulse event due to the reflected pressure pulse wave at t 2, a turning point.
  • the pulse wave transit time PTT] (Lo + Li) is defined as the transit time of the pressure pulse wave caused by cardiac contraction due to the distance traveled in the aortic arch and in the brachial artery and the radial artery to the pressure measuring point 12 in FIG.
  • the pulse wave transit time PTT 2 (Lo + 2 L 2 + L) is defined as the transit time of the pressure pulse wave reflected at the aortic bifurcation due to the distance traveled in the aortic arch, twice the length of the descending aorta, and brachial artery and radial artery to the pressure measurement site 12 in Figure 1.
  • the pulse wave transit time in the descending aorta PTT (2 L 2 ) is defined as the transit time difference between the pressure pulse wave caused by cardiac contraction and the pressure pulse wave reflected at the aortic bifurcation of the descending aorta due to the traversed double length of the descending aorta.
  • the length of the descending aorta results from FIG. 1 as dimension L 2 .
  • the pulse wave transit time in the descending aorta PTT can be calculated as the difference between the pulse wave transit time PTT 2 and the pulse wave transit time PTTj, as shown in Equation 1.
  • the practical calculation of the pulse wave transit time is carried out using known mathematical methods with a calculation algorithm for evaluating the time course of measured pressure pulse waves, which determines in particular maxima and inflection points and calculates the measurement times of maxima and inflection points.
  • the calculation algorithm may be configured to smooth the measured pressure pulse waves.
  • the calculation algorithm may be configured to calculate the first derivatives and the second derivatives of the smoothed pressure pulse waves.
  • the calculation algorithm may be configured to extract and analyze at least one single pulse pressure curve from a plurality or a plurality of pulse pressure curves.
  • the analysis of the at least one pulse pressure curve may include some, several or all of the following steps.
  • the calculation algorithm may be configured to detect the systolic peak at the time and the peak of the reflection wave at time t 2 from the waveform of an extracted pulse pressure curve.
  • the calculation algorithm can be configured, for example, to check the plausibility, in addition to recognize the diastolic peak at time t 3 from the curve of an extracted pulse pressure curve.
  • the calculation algorithm may be configured to set a replacement point for the peak of the reflection wave at time t 2 if the analysis of the curve does not provide a unique peak.
  • the calculation algorithm can assign a point of inflection from the curve as a substitute point for the peak of the reflection wave at time t 2 .
  • the calculation algorithm may be configured to calculate the descending aorta pulse wave velocity PWV from the descending aortic pulse transit time PTT and the particular patient's descending aortic length.
  • the calculation algorithm may also be configured to calculate statistical quantities such as the mean and standard deviation of the descending aorta pulse wave velocity PWV and / or the descending aortic pulse wave transit time PTT.
  • the calculation algorithm for evaluating the time course of measurement curves is part of a computer program with program code which is stored in the measuring and arithmetic unit and causes the mechanical steps of the method according to the invention when the program code runs in the evaluation unit of the measuring and arithmetic unit.
  • Equation 2 Using the pulse aortic PTT (2 L 2 ) pulse wave transit time, the pulse wave velocity resulting from Equation 2 can be calculated.
  • the length L 2 of the descending aorta of a particular patient is determined in the present embodiment with the calculation approach from equation 3.
  • LJS means the distance between the jugulum and the pubic symphysis of the particular patient lying, and kjs a correction factor, the amount of which is preferably in the range between 0.6 and 1.0. Particularly preferably, the amount of the correction factor is 0.8.
  • the decreasing correction factor kjs takes into account the fact that the theoretical distance LJS between the jugulum and the symphysis pubica of a recumbent patient is slightly longer than the actual length of the descending one Aorta.
  • the correction factor kjs is patient-specific, but it is possible to determine the correction factor as an average value from empirical investigations on a representative patient collective to simplify the evaluation. An average of the correction factor can be determined, for example, from angiographic MRI image files and used as a constant in all calculations.
  • the determination of the length L 2 of the descending aorta is non-invasive.
  • the length L 2 of the descending aorta of a particular patient may also be calculated using the calculation approach shown in Equation 4.
  • LJBS means the distance between the sternal notch and the Navel (umbilicus) of the particular patient is lying down and kj ß an empirically determined correction factor, the amount is preferably in the range between 0.8 and 1 second More preferably, the amount of the correction factor is about 1.0.
  • the advantage of this alternative approach is that the attending physician can determine the correction factor kj Bs at any time by simple external length measurement on the patient lying down. This alternative determination of the length L 2 of the descending aorta is non-invasive.
  • the length L 2 of the descending aorta of a particular patient can also be determined with the numerical value equation shown in Equation 5, which was determined on the basis of investigations on a subject collective by the applicant of the present patent application.
  • H means the body size of the particular standing patient to be inserted into the numerical value equation in the unit centimeters.
  • the length L 2 of the descending aorta is obtained with this numerical equation in the Unit of millimeters. This further alternative determination of the length L 2 of the descending aorta is non-invasive.
  • the calculation of the length L 2 of the descending aorta of the particular patient is carried out once non-invasively in the present embodiment by the attending physician.
  • the calculation result is stored on the electronic patient card of the particular patient stored to perform future calculations of the electronic patient card and is then available for the calculation.
  • the measuring and calculating unit of the present embodiment optionally connects the execution of the method according to the invention with a known method for continuously calculating and monitoring the absolute and / or relative blood pressure change of the patient according to equation 6 for the absolute blood pressure change and / or according to equation 7 for the relative blood pressure change and / or according to the equation 8 for calculating the blood pressure each alone based on the evaluation of a piezoelectric pressure measurement of the radial pulse on the wrist of the patient using the equation 2 for calculating the pulse wave velocity in conjunction with one of the equations 3 to 5.
  • ABP (t) m ⁇ [PWV (t) - PWV (t 0 )] + n in mmHg
  • Equation (6) m - [PWV (t) -PWV (t 0 )] + n
  • BP is the blood pressure in mmHg
  • m is a constant with the unit mmHg / [m / s]
  • n is a contour with the unit mmHg
  • t is the time
  • t 0 is a reference time.
  • the two constants m and n can be determined by calibration measurements for at least two different pressure states.
  • the PWT of the descending aorta and the pulse wave velocity PWV of the descending aorta can be calculated, and a continuous blood pressure measurement without the use of additional measurement methods such as Photople hysmogramm (PPG) and electrocardiogram (ECG ), whereby the aforementioned practical disadvantages and acceptance problems of the use of such additional measurement methods as PPG and ECG in the context of continuous blood pressure measurement are avoided.
  • PPG Photople hysmogramm
  • ECG electrocardiogram
  • FIG. 3 shows a schematic representation of the measuring and calculating unit 100 according to the invention in an arrangement for measuring the pressure pulse on the wrist of a patient.
  • the measuring and computing unit 100 contains a pressure measuring unit 10, an evaluation unit 20 and a read / write device 30 for storing data on a patient card 31.
  • the electronic patient card has an electronic data memory 32.
  • the pressure measuring unit 10 is connected via a measuring cable 11 with a piezoelectric pressure sensor 12, which is fastened in the illustrated arrangement on the wrist of a patient. It is alternatively also a wireless transmission of the pressure signal of the sensor 12 to the pressure measuring unit 10, for example a transmission by radio possible.
  • the evaluation unit 20 contains a data input unit 21, a computing and storage unit 22 and a display unit 23.
  • the data input unit 21 is connected to the computing and storage unit 22 via a data line 24.
  • the display unit 23 is connected to the computing and storage unit 22 via a data line 25.
  • the computing and storage unit 22 is connected via a data line 26 to the reader / writer 30 for a patient card 31.
  • the arithmetic and memory unit 22 includes in its memory a computer program with program code for initiating the mechanical steps of the method according to the invention when the program code runs in the arithmetic and memory unit 22 of the measuring and arithmetic unit 100.
  • FIG. 4 shows a schematic representation of the measurement and computation unit 100 according to the invention from FIG. 3 in conjunction with a blood treatment machine 1000.
  • the measurement and computation unit 100 is part of the control and computation unit of the blood treatment machine.
  • the writing and reading device for the electronic patient card is part of the blood treatment machine and is in communication with the control and processing unit of the blood treatment machine.
  • the control and processing unit is connected to a touchscreen 1100.
  • the data input unit 21 and the display unit 23 are part of the touch screen of the blood treatment machine.
  • the control and computing unit is configured to input user input via the touchscreen and to display the calculation results on the touchscreen and to store patient-related data of a specific patient, in particular the calculated values of the at least one characteristic for the arterial vascular stiffness of the particular patient for the plurality of successive measurement intervals as a time series, on the patient card 31 of the particular patient.
  • the attending physician uses a measuring and calculating unit 100 according to one of the arrangements in FIG. 3 or FIG. 4 and, before the beginning of a first time interval, enters the amount of the length of the descending aorta for the particular patient by means of the data input unit 21 into the measuring unit. and arithmetic unit 100. Further data of the particular patient, for example his age, can be entered.
  • the attending physician places the pressure sensor on the pressure measuring point 12 on the wrist of the particular patient and starts the measurement of at least one pressure pulse wave.
  • the electrical measurement signal of the pressure sensor for the time course of at least one pressure pulse wave per time interval is converted by the pressure measuring unit 10 into a pressure curve and forwarded to the computing and storage unit 22.
  • a computer program according to the invention executes program code and calculates the descending aortic pulse wave velocity as a characteristic parameter for the arterial vascular stiffness of the particular patient, sequentially stores the pulse wave velocity amounts for all time intervals, and sets the time series
  • the pulse wave transit time of the descending aorta could also be used as a characteristic of arterial vessel stiffness because the pulse wave velocity and pulse wave transit time are inversely proportional to each other, with the length of the descending aorta being considered to be constant is assumed (see equation 2).
  • FIG. 5 shows, for a display unit 23 according to FIG. 3 or FIG. 4, the graphic representation of the trend of the characteristic parameter for the arterial stiffness as a function of time with predetermined value ranges Ii, I 2 and I 3 for the characteristic parameter of the vessel stiffness, where Ii , a value range of normal arterial vascular stiffness corresponding to the age of the particular patient, I 2 a range of values of increased arterial vascular stiffness, and I 3 the range of values of critically increased arterial vascular stiffness.
  • the value ranges can be set in be ergonomically different colors, for example green for 1 ⁇ (values inconspicuous), yellow for I 2 (warning area) and red for I 3 (danger area). If the trend reaches the warning zone or even the danger zone, this indicates to the attending physician the need for a control measurement and / or the initiation of medical countermeasures.
  • Control measurements which are not the subject of the present invention, can be carried out for example by means of angiography and / or computed tomography and / or magnetic resonance tomography.
  • the subdivision of the time axis of the plot of the trend of the characteristic parameters for the arterial vascular stiffness can optionally represent a plurality or a plurality of weeks, months or years.
  • the time series is supplemented and updated after each time interval for the particular patient.
  • the updated time series is forwarded by the computing and storage unit 22 to the read / write device 30 and stored on the patient card 31 of the particular patient.
  • the measuring and computing unit 100 may include, for example, one of the two hardware arrangements described below, which are described by way of example with reference to the measurement with a pressure measuring cuff on the upper arm of a patient, but are not limited thereto.
  • the pressure measuring cuff When measuring with a pressure measuring cuff on the upper arm of a patient, the pressure measuring cuff is inflated to an over-systolic pressure, for example to a pressure which is 40 mmHg above the systolic arterial blood pressure. This so-called cuff pressure is maintained during the measurement period. During the measuring period, pressure oscillations are measured. The total amplitude of the pressure measuring signal is therefore composed of a proportion due to the cuff pressure (so-called DC component) and an additive component due to the pressure oscillations (so-called AC component).
  • DC component proportion due to the cuff pressure
  • AC component additive component due to the pressure oscillations
  • the amount of the share is due to the Cuff pressure much greater than the amount of the portion due to the pressure oscillations, for example, the proportion due to the pressure oscillations less than 5% of the proportion due to the cuff pressure.
  • the proportion due to the pressure oscillations contains the desired information about the arterial vascular stiffness and is to be extracted from the entire amplitude of the pressure measuring signal.
  • the pressure measurement signal is fed to an analog high-pass filter, for example with a cut-off frequency of 0.10 Hz.
  • the DC component is suppressed.
  • the filtered signal corresponds to the AC component due to the pressure oscillations and is fed to an analog low-pass filter, for example with a cutoff frequency of 20 Hz.
  • the filtered signal from the low-pass filter is amplified and fed to an analog-to-digital converter (abbreviated to "ADC") with a resolution of 12 bits and digitized.
  • ADC analog-to-digital converter
  • the digital signal from the 12-bit ADC becomes In this hardware arrangement, therefore, the pressure measurement signal is first filtered and then amplified and digitized.
  • This first hardware arrangement experiences signal settling times of approximately 20 seconds, which require a correspondingly long duration of measurement on the patient High-pass filter and an analog low-pass filter, the cut-off frequencies are subject respectively to the component-specific tolerances of the analog filter, which can be between 10% and 20% of the cutoff frequency, for example, in conventional capacitors.
  • the pressure measurement signal is first amplified and then digitized by means of a high-resolution analog-to-digital converter with a resolution of, for example, 24 bits.
  • the digitized pressure measurement signal is then filtered by means of a digital high pass filter, for example with a cutoff frequency of 0.10 Hz and a digital low pass filter, for example with a cutoff frequency of 20 Hz, so that the AC component is extracted. Only then is the digitized and filtered pressure measurement signal (AC component) evaluated according to the invention.
  • the second hardware arrangement has the advantage that the signal settling times occurring in the case of the first hardware arrangement are dispensed with in the second hardware arrangement.
  • the acceptance the patient for the measurement process for determining the vascular stiffness can be further increased because the duration of the load of the humeral tissue due to the cuff pressure can be reduced by eliminating the signal settling times.
  • the cut-off frequencies of the digital high-pass filter and the digital low-pass filter are adjustable by means of suitable software. Therefore, the problem of the component-specific tolerances of the cutoff frequency of the analog filters as described in the first hardware arrangement does not occur in the second hardware arrangement. The reliability of the device according to the invention can therefore be further improved by using a second hardware arrangement.
  • the solution of the problems of the present invention succeeds with the embodiment shown.
  • the present invention is not limited to the embodiment.
  • Aorta (aortic bifurcation)

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physiology (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ophthalmology & Optometry (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

La présente invention propose un procédé et un dispositif pour la surveillance à long terme de la rigidité artérielle et de la calcification des vaisseaux sanguins d'un patient donné, une caractéristique pour la rigidité artérielle étant déterminée exclusivement à partir de la forme ou de l'allure d'au moins une onde de pulsation de pression provoquée par une contraction cardiaque en fonction du temps et enregistrée pour la patient donné sous forme de série temporelle. Dans des formes de réalisation particulièrement préférées, la caractéristique est représentée sous forme de tendance et sert de base au médecin pour une surveillance à long terme de la rigidité artérielle.
EP13718111.1A 2012-04-11 2013-04-11 Procédé et dispositif pour la surveillance à long terme de la rigidité artérielle et de la calcification des vaisseaux sanguins d'un patient Withdrawn EP2836112A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261622667P 2012-04-11 2012-04-11
DE102012007081.0A DE102012007081B4 (de) 2012-04-11 2012-04-11 Verfahren sowie Mess- und Recheneinheit zur langfristigen Überwachung der arteriellen Gefäßsteifigkeit und Gefäßkalzifikation eines Patienten
PCT/EP2013/001057 WO2013152854A1 (fr) 2012-04-11 2013-04-11 Procédé et dispositif pour la surveillance à long terme de la rigidité artérielle et de la calcification des vaisseaux sanguins d'un patient

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EP2836112A1 true EP2836112A1 (fr) 2015-02-18

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US (1) US10016138B2 (fr)
EP (1) EP2836112A1 (fr)
CN (1) CN104203086B (fr)
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WO (1) WO2013152854A1 (fr)

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WO2013152854A1 (fr) 2013-10-17
DE102012007081A1 (de) 2013-10-17
CN104203086B (zh) 2018-03-06
US20130274620A1 (en) 2013-10-17
CN104203086A (zh) 2014-12-10
US10016138B2 (en) 2018-07-10
DE102012007081B4 (de) 2015-04-02

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