• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The respiration device with an adjustable pressure and volume course has a control and evaluation unit which is arranged to determine the resistance R and the alveolar pressure Piv (t) and to examine the functional dependence of Piv (t) and the breathing volume Vol (t) against time intervals. in which a measure of the goodness of a linear functional dependence on Piv (t) and meets a predetermined threshold criterion, and only in the time intervals determined in this way determine the elasticity E or compliance C from the increase of the alveolar pressure Paiv (t) in dependence of the volume Vol (t). (Fig. 2)
    公开号:SE1000128A1
    申请号:SE1000128
    申请日:2010-02-10
    公开日:2010-12-06
    发明作者:Marcus Eger；Thomas Handzsuj；Zhanqi Zhao；Knut Moeller
    申请人:Draeger Medical Ag；
    IPC主号:
    专利说明:

    15 20 25 30 2 by active respiration. Maintaining spontaneous breathing is today a priority goal in clinical treatment.
    Knowledge of the lung mechanical parameters is necessary to be able to set the support values Flow-Assist (FA) and Volume-Assist (VA) for proportionally supported respiration (PAV or PPS). Adjustment of the support is necessary not only at the beginning but at all times during the process, as the lung mechanical properties can change, for example when changing or due to the formation of mucus. As this can only be realized with difficulty in clinical everyday life, there is a legitimate concern among physicians to cause Run-Aways (ie an overcompensation which results in an instability in respiration mode and which in the event of incorrectly set alarm limits could expose patients to danger or at least increase their respiratory work), there is for this type of proportionally supported respiration despite its physiological benefits only little practical acceptance.
    In “Proportional Assist Ventilation” procedures (see, e.g., Younes, M .: “Proportional Assist Ventilations” in: Tobin MOJ., Ed. “Principles and practice of mechanical ventilation”, New York, McGraW- Hill, 1996, pp. 349-369) generates a pressure support which includes a proportion which is proportional to the current volume fl desolation (Flow) and a proportion which is proportional to the volume. The degree of support is given by the adjustment values Flow-Assist (FA) and Volume-Assist (VA).
    Through the positive feedback of volume fl fate and volume, this form of respiration realizes a kind of Power Steering, which makes it possible to separately compensate for proportions of the resistive and elastic resistances in the respiratory system and thereby treat the patient's breathing work in a quantitative way. In addition, a sufficiently accurately estimated value for the actual resistance (R) and elastane (E) must be available, as otherwise instabilities (so-called Run-Aways) could occur, and possibly also damage to the lungs due to barotrauma.
    Furthermore, efforts have long been made to determine R and E during spontaneous respiration in a reliable and minimally invasive manner (see, for example, WO 97/22377 A1). The particular difficulty lies in the fact that the patient's spontaneous breathing activity can cause large estimation errors in determining the respiratory mechanical parameters. A well-known procedure is the introduction of disturbing maneuvers into the breathing pattern (eg through a short-term occlusion) at times when a passive breathing phase is assumed, and subsequent analysis of the disturbed respiratory signals. Admittedly, it is not guaranteed that the patient is in an undisturbed phase of the respiratory cycle at the time of the maneuver, and thus the validity of the measurement is not guaranteed; nor can it be subsequently detected. This is because the respiratory muscle activity can be separated from the mechanical breathing pattern due to strong correlations, neither signal-theoretically nor statistically.
    From the company Covidien / Tyco / Puritan / Bennett, the respiration device PB84O with respiration mode PAV + has been marketed, which will deliver an automatic setting of the support. The established parameters for the resistance (R) and the elastane (E) resp. compliance (C = 1 / E) is inaccurate, which is why safe compensation of the breathing work is only possible at low degrees of support, (ie at low support values FA and VA).
    The respirator PB840 with the implemented procedure PAV + also uses occlusions, ie short-term shutdowns of the respiratory gas supply to the patient, after the end of the patient's inhalation. These occlusions are relatively long (300 ms) and therefore significantly interfere with the patient's breathing pattern. Furthermore, occlusion occurs at a time in the respiratory cycle at which there is often severe respiratory activity in the patient - in contrast to what would be assumed for the effect of the procedure. This results in errors in the calculation of the lung mechanical parameters Resistance (R) and Elastane (E), as well as a high spread of the numerical values. As these parameters R and E are used for setting the support values FA and VA, a safe compensation of the breathing work is consequently only possible within the framework of low support values.
    The object of the present invention is to provide a respiratory device and a method for its automatic control, by means of which the elastane resp. compliance can be determined more accurately and more reliably. To solve this problem, the respiratory device with the features according to claim 1 and the method for its operation according to claim 1 serve. Preferred embodiments of the invention are stated in the subclaims.
    The respiration device according to the invention has a fan for supplying breathing gas with an adjustable pressure or volume flow rate, devices for recording measured values regarding respiratory tract pressure (Paw (t) and volume fl Desert Flow (t) and for determining the breathing volume Vol (t) and a control and The control and evaluation unit is first and foremost arranged to determine the resistance R, whereby for this purpose the method described in the patent application EP 1 972 274 A1 using very short occlusions of approximately 100 ms can be applied; the resistance can be determined by the article “Proportional Assist Ventilation” by Younes discussed in the ode above or by a conventional procedure, in which the patient is passive (eg anesthetized) or by any other known method. determination of the resistance by repeated short occlusions (so-called P0.1 occlusions) is preferred, since these PO, 1 occlusions are so short that they are hardly perceived by the patient and thereby do not interfere with respiratory activity. Furthermore, they are clinically accepted and are used repeatedly, for example within the framework of weaning, to measure respiratory function.
    The control and evaluation unit is prepared to determine the resistive pressure component Flow (t) * R from the measured value of the volume fl Flow (t) and the determined value of the resistance R and subtract it from the measured respiratory pressure Paw (t), for to thus determine the alveolar moment Pa1v (t) and register as a function of time.
    The control and evaluation unit is furthermore according to the invention prepared for analyzing and at certain time intervals scanning the functional dependence of Pak, (t) and Vol (t), namely by reducing the dependence on Pak, (t) and Vol (t) with variables. time intervals are examined at time intervals in which a measure of goodness (Gute) for a linear functional dependence on Pa1v (t) and Vol (t) meets a predetermined threshold criterion of 10 15 20 25 30, ie. variable interval lengths are searched for time intervals in which there are only minimal deviations from linearity, so that in this way phases in which there is a strongly variable spontaneous respiration are omitted, so that error errors due to spontaneous respiration are reduced. Only in the time intervals thus determined is the elasticity or compliance finally determined from the rise of the alveolar pressure (Pa fl t) depending on the volume Vol (t).
    As a measure of the goodness number (die Güte) for the linear functional dependence, in the time intervals with variable interval length a linear regression can be performed and a function that cumulates the residues from the linear regression, e.g. variance, is subjected to a predetermined threshold criterion, whereby the variance is obtained from the sum of the square residues (the deviation of the straight line from the measuring points). The variance can be used, for example, to determine the confidence limits at a predetermined percentage, preferably 95% confidence limit, for the parameters determined by the linear regression, and these confidence limits can be subjected to a predetermined threshold criterion.
    It has been found that a particularly sensitive measure of the goodness of the linear functional dependence can be obtained by determining the difference between the capacitance limits of the elastane determined in the regression and this difference is normalized to the root of the number of data values in the time interval and that determined in the regression. the value of the elastane; the value formed in this way constitutes, so to speak, a standardized error interval, for which it may be required to be below a predetermined threshold value, which means that the elasticity (compliance) determined in the linear regression has a small error.
    Alternatively, the control and evaluation unit may be prepared to perform linear regressions in the time intervals with variable interval lengths as a measure of the goodness of linear functional dependence and to use the correlation coefficient for the regressions in question as a measure of goodness, whereby a minimum threshold is given in advance. deviation of the correlation coefficient from 1 is allowed. 10 15 20 25 30 6 Preferably, the control and evaluation unit is further prepared so that if it is registered within a breathing cycle tids your time intervals that meet the threshold criterion, they summarize the values for the elasticity (or compliance) calculated in these time intervals by first and foremost a cantilever test. are implemented and established outliers are rejected and the remaining care is summarized at an average or median value. In addition, the control and evaluation unit can be prepared to summarize the values for the elasticity (or compliance) calculated in fl your time intervals over successive breaths, by first and foremost performing an outrigger test and rejecting established outriggers and summarizing remaining values to an average or median value. .
    The elasticity or compliance determined in accordance with the invention with the device or method can then be used together with an arm-determined resistance for different purposes: - for setting the degree of support in proportional pressure support (Proportional Pressure Support or Proportional Assist Ventilation), - for automatic setting of a ramp at Pressure Support as described in DE 10 2007 033 546 BS, - for the use of gas exchange models for optimized respiration, - for diagnostic or monitoring systems, - for calculation of the respiratory muscle pressure (Pmus), - to thereby be able to begging or terminating mechanical breathing, - to serve as a difference signal for scaling a non-pneumatic muscle activity signal, for example the sEMG signal, as described in patent application DE 10 2007 062 214, - to be used in determining the degree of respiratory muscle fatigue, - to be used in a strategy for weaning respiration, - to be generally announced for d diagnostic and monitoring purposes, - to be used for medical decision support, for example early determination of the time of extubation.
    The invention is further elucidated in connection with the fi gures, on which: Fig. 1 shows the dependence of the volume on the alveolar pressure for an example of a breath, and Fig. 2 shows the dependence of the volume, the alveolar pressure and the estimated muscle pressure of the time for the same exemplified breath from fi g. 1.
    In the light of the present invention, the elasticity resp. compliance is well determined in such phases in which the respiratory muscle activity remains sufficiently constant. Assuming an l-space model, the relationship between muscle activity Pmusßz), the pulmonary mechanical parameters (R and E) and the respiration signal paw (t), volume fl fate Flow (t), volume Vol (t) the so-called the motion equation Pmusü) + Pkw (t] = = R * Flow (t) + E * Vol (t) + PEEPi PEEPi is here the so-called intrinsic PEEP, ie the (relatively constant), in the lung remaining pressure after exhalation. Assuming that the muscle activity is a constant time window, ie pmus (t) = K, subtracting the resistive pressure component R * Flow (t) from the respiratory wave pressure paw (t), one obtains the alveolar pressure Palv (t) to Pa1v (t) = E * Vol (t) + PEEPi - K.
    This equation shows that the elasticity E can be determined by regression between the variables Pak, (t) and Vol (t) assuming a constant muscle activity (pmus = K.
    In spontaneously breathing patients, however, the pmus (t) changes continuously. An essential feature of the present invention is to automatically create such time intervals or time windows in which pmus (t) are sufficiently constant, these time intervals being identified by shifting time intervals of variable interval length 10 the respiration cycle, and for each a linear regression of Pak, (t) and Vol (t) is performed and a measure of the goodness of the fit is determined. Preferably, the variance is subjected to the linear regression in question resp. the 95% confidence limits derived therefrom are a threshold criterion for determining the goodness of linear dependence. For this purpose, iterative regressions are performed with different time interval lengths and time interval modes until a time interval is found in which the condensation interval for the calculated elastane value is below a predetermined minimum level value. This is then the case when the pmus (t) in the interval found in this way is sufficiently cash and at the same time a decisive volume change takes place, so that a determination of the elasticity is possible without disturbance due to muscle activity.
    Fig. 1 shows a representation of the volume depending on the alveolar pressure for an example of a breath. With a respiratory device according to the invention, the dependence of the alveolar pressure on the volume was analyzed in fl consecutive steps while varying time interval lengths and positions for the time intervals by performing a linear regression of the dependence for each successive time interval and determining a measure of goodness, and was subjected to a threshold criterion, using in the present case the difference between the 95% confidence limits of the value determined in the linear regression for the elastance E normalized to the root of the number of data values in the time interval, and that determined for the elastance E, and the this value was required to be less than a pre-given minimum value. The subsequently determined time intervals are each marked by their start point (unfilled circle) and end point (filled circle). The thickly drawn lines between the start and end points in question constitute regression lines, for which the elasticity is calculated. The established regression lines are essentially parallel to each other, ie. the elastane values determined in the time interval in question hardly vary.
    Fig. 2 shows a representation of the time dependence of the quantities volume (Vol (t), dotted line), the alveolar pressure (Pa1v (t), solid line) and the estimated muscle pressure (Pmus (t), dashed curve) for the same exemplary breaths as in Fig. 1. The time intervals determined according to the invention are marked by their 9 resp. starting point (dashed vertical line) and end point (solid vertical line) as well as through thick horizontal beams. From the comparison with the curve of the estimated muscle pressure Pmus (t), it was found that the time intervals determined in accordance with the dependence on Pa1v (t) and Vol (t) identify actual time intervals, in which the connecting calculated muscle pressure Pmus (t) t) does not substantially change.
    权利要求:
    Claims (10)
    [1]
    Respiratory device with a ventilator for supplying breathing gas with an adjustable pressure or volume flow rate, devices for recording measured values for operating path pressure Paw (t) and volume fl deserted Flow (t) and for determining the breathing volume Vo1 (t) and a control and evaluation unit, which is arranged to determine the resistance R and by subtracting the resistive pressure component Flow (t) * R from the measured airway pressure apaw (t) determine the alveolar pressure Pa fl t) and record as a function of time, to analyze the functional the dependence of Paiv (t) and Vo1 (t) in such a way that the functional dependence of Pa1., (t) and Vo1 (t) is examined with variable interval lengths versus time intervals, in which a measure of the goodness of a linear function dependence on Paiv (t) and Vol (t) meets a predetermined threshold criterion, and only in the time intervals thus determined determine the elastane E or compliance C from the increase of the alveolus honor txycket Palv (t) depending on the volume Vo1 (t).
    [2]
    Respiratory device according to claim 1, wherein the control and evaluation unit is prepared to, as a measure of the goodness of the linear functional dependence on Pak, (t) and Vol (t), if necessary, perform linear regressions in the time intervals with variable interval lengths and wherein a function of the residues for the linear regression, e.g. variance, is subject to a pre-given threshold criterion.
    [3]
    Respiratory device according to claim 2, wherein the control and evaluation unit is prepared to determine resp. variance for the linear regression and hence the condensate limits to one on. predetermined percentage, preferably the 95% condensate limit, and subjecting the condensate limit to a predetermined threshold criterion.
    [4]
    Respiration device according to claim 3, wherein the control and evaluation unit is prepared to, as measured by the goodness of the regression, form the difference of the confidence limits and normalize this difference to the root of the number of data values in the time interval and that determined in the regression. the value of the elasticity, and as a threshold criterion require that the result is less than a predetermined value.
    [5]
    Respiratory device according to claim 1, wherein the control and evaluation unit is prepared to perform as a measure of the goodness of the linear functional dependence of Pak (t) and Vol (t) linear regressions in the time intervals with variable interval lengths and as a measure of the goodness use the correlation coefficients for the regressions in question, whereby as a pre-given threshold criterion a minimal deviation of the correlation coefficient from 1 is allowed.
    [6]
    Respiration device according to claim 1, wherein the control and evaluation unit is prepared to perform as a measure of the goodness of the linear functional dependence of Pak, (t) and Vol (t) in the time intervals with variable interval lengths resp. hypothesis tests for the hypothesis that it is a linear dependence, and as a pre-given threshold value require a significance level for the hypothesis test of at least 95%.
    [7]
    Respiratory device according to one of the preceding claims, wherein the control and evaluation unit is prepared for summarizing the values for compliance or elastane calculated in these time intervals if a time interval is recorded within a breathing cycle, in that first a Outrigger tests are carried out and established outriggers are rejected and the remaining values are summarized at an average or median value.
    [8]
    Respiratory device according to one of the preceding claims, wherein the control and evaluation unit is prepared to summarize the values for compliance or elasticity calculated in fl your time intervals over successive breaths, by first and foremost carrying out an outrigger test and determining outriggers. are rejected and the remaining values are summarized as an average or median value. 10 15 20 25 12
    [9]
    Respiratory device according to one of the preceding claims, wherein the control and evaluation unit is prepared for using the determined resistance and elastane / compliance for setting the degree of support in proportional pressure support (proportional pressure support or proportional assist ventilation).
    [10]
    Respiratory device according to any one of the preceding claims, wherein the control and evaluation unit is prepared to calculate the pressure generated by respiratory muscle activity pmusü) according to the equation pmusü) + Paw (t) = R * Flow (t) + E * Vol (t ) + PEEPi. 1 1. Procedure for the automatic operation of a respirator with a ventilator for supplying breathing gas with an adjustable pressure or volume flow rate, in which a control and evaluation unit records measured values for respiratory pressure Paw (t) and volume fl Desert Flow ( t) and the respiration volume Vol (t) and the resistance are determined and by subtracting the resistive pressure component Flow (t) * R from the measured respiratory wave pressure Paw (t) the alveolar pressure Pa1v (t) is determined and recorded as a function of time, whereby in control and the evaluation unit analyzes the functional dependence of Pa fl t) and Vol (t) in such a way that the functional dependence of Pa1v (t) and Vol (t) is examined with variable interval lengths versus time intervals, in which intervals a measure of the goodness of a linear functional dependence on Pa1v (t) and Vol (t) is above a predetermined threshold, and the elasticity or compliance is determined only in the thus determined time intervals from the Pa1v (t) of the alveolar pressure in depending on the volume Vol (t), and the control and evaluation unit controls the fan for generation depending on the so-called elasticity or compliance a de fi denied pressure door passage.
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    同族专利:
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    法律状态:
    2011-11-29| NAV| Patent application has lapsed|
    优先权:
    申请号 | 申请日 | 专利标题
    DE102009023965A|DE102009023965A1|2009-06-05|2009-06-05|Respiratory device for pressure-supporting ventilation of patient, has control and evaluation unit analyzing functional dependency of pressure and respiratory volume, where elastance or compliance is determined from rise of pressure|
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