The invention relates to monitoring cardiac activity of a patient.
Several semi- or non-invasive cardiac output (CO) tracking techniques considered to be a current state-of-the-art have some positionally significant limitations and ambiguities. Some of them require not only an arterial catheterization, but the additional operator inputs of the patient-specific characteristics (e.g. gender, age, weight), features of the pressure waveform (e.g. skewness, kurtosis). Some of these techniques are also based on the numeral assumptions (e.g. constant cross-sectional area of the vessels over time, ideal geometry of the anatomic structures, flat flow velocity profile, etc). These limitations are especially relevant in the case of monitoring cardiac function.
It is also known to provide a non-invasive pulse spectroscopy system for real time monitoring of cardiac activity. The following references relate to the field of non-invasive blood monitoring using optical emitters and detectors.
Also, U.S. Pat. No. 6,325,762 describes a system for cardiac output monitoring, in which resistance within the blood vessel is measured. US2011172518 describes an approach in which a permanent magnet arrangement is used for non-invasive measurement of cardiac output. US2010222658 describes an approach in which reflection of light of different wavelengths from external tissue is measured. US2010152591 describes an approach in which an acoustic energy transducer provides sensing data.
The invention is directed towards achieving improved cardiac activity monitoring.
According to the invention, there is provided a system for non-invasive monitoring of cardiac activity in a human or animal, the system comprising:
In one embodiment, the processor is adapted to perform tracking of a cardiac output trend in addition to or instead of an absolute cardiac output value.
In one embodiment, the radiation source and the detector are arranged to operate on either the transmissive or the reflectance principles.
In one embodiment, the system is adapted to acquire a non-invasive signal by irradiating a measuring site with the radiation source operating at a wavelength on a haemoglobin spectral isosbestic point, in which radiation is modulated thereafter by blood circulation activity.
In one embodiment, the processor is adapted to perform numerical integration of pulse data between troughs, and wherein said integration is performed per pulse.
In one embodiment, the processor is adapted to convert said indicator data to cardiac output data by usage of a predefined calibration curve based on cardiac output values from a large patient pool.
In one embodiment, the processor is adapted to perform numerical integration of pulse data between troughs, and wherein said integration is performed per pulse; and wherein the processor is adapted to integrate by executing an adaptive function.
In one embodiment, the processor is adapted to calculate cardiac output values correlating with beat volume units based on the terms of a predetermined empirical calibration curve derived from thermodilution measurements of cardiac output.
In one embodiment, the processor is adapted to calculate cardiac output values based on a predetermined empirical calibration curve derived from thermodilution measurements of cardiac output, to determine beat volume units based on stroke index, and to combine the beat volume units with cardiovascular characteristics of a patient.
In one embodiment, the processor is adapted to determine cardiac output measurement data and to calibrate said data using a thermodilution technique. Preferably, the processor is adapted to execute an autoregulatory compensation algorithm.
In one embodiment, the system comprises a plurality of pairs of radiation sources and detectors, and the processor is adapted to process data from said plurality of detectors.
In one embodiment, the system comprises a plurality of pairs of radiation sources and detectors, and the processor is adapted to process data from said plurality of detectors and said sensors, and the system further comprises at least one non-optical sensor; and said non-optical sensor includes at least one ECG sensor.
In one embodiment, the processor is adapted to estimate haemoglobin content and blood oxygen concentration, and to derive from said estimations an estimate of total oxygen uptake.
In another aspect, the invention provides a method for non-invasive monitoring of cardiac activity in a human or animal, the method comprising:
In one embodiment, the processor performs tracking of a cardiac output trend in addition to or instead of an absolute cardiac output value.
In one embodiment, the radiation source emits radiation with wavelength at haemoglobin or SpO2 spectral isosbestic points, in which radiation is modulated thereafter only by blood circulation activity.
In one embodiment, the processor performs numerical integration of pulse data between troughs, and wherein said integration is performed per pulse.
In one embodiment, the processor converts indicator data to beat volume units.
In one embodiment, the processor performs numerical integration of pulse data between troughs; and wherein the processor integrates by executing an adaptive function.
In one embodiment, the processor calculates cardiac output values correlating with beat volume units based on the terms of a predetermined empirical calibration curve derived from thermodilution measurements of cardiac output.
In one embodiment, the processor calculates cardiac output values based upon an equation combining beat volume units with individual cardiovascular characteristics of a patient.
In one embodiment, the radiation source and the detector are applied at a peripheral patient location.
In one embodiment, the processor executes an autoregulatory compensation algorithm.
In a further aspect, the invention provides a computer readable medium comprising software code adapted to perform, when executed by a digital processor, a method comprising the steps of:
The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only with reference to the accompanying drawings in which:
Referring initially to
As shown in
In more detail, the sensed radiation pulses are recognized by the processor. Importantly, the pulse area is calculated. This provides an integration of the pulse. After calibration, an output of cardiac activity is generated.
As shown in
The maxima and minima of the f(t) plot are represented by the zero values in the f′(t) plot, where the first derivative function f′(t) closes the zero-line. These zero values provide boundaries for the processor to calculate the area under the f(t) curve, as shown in
A transmission measuring principle is used to transmit light at different frequencies through the subject's tissues and thereafter to determine the pulsatile and non-pulsatile components of the received light at the sensor site (see
where At is a total absorbance of a medium with n absorbing substances, e, c and d are respectively the extinction coefficient, molar concentration of absorbing species in the material, and optical path length of the ambient, λ—wavelength.
In order to compensate for the changes in a radiation source intensity, every pulse square S1(AC) is normalized with the square of non-pulsatile part S2(DC) giving a so called stroke index (SI):
SI=S1(AC)/S2(DC)
A value of the SI is then used by the algorithm as a key element in cardiac output estimation. S1(AC) represent a pulsative blood volume and S2(DC)—constant non-pulsative blood volume (e.g. soft tissues, bones). SI correlates with a total blood volume being circulated in the body.
for i=0, 1, 2, . . . , n-1,
where n is the number of samples in f(t).
In order to distinguish the troughs framing individual pulses, a threshold for the 1st derivative of the original data was set. Thus, the individual processing windows are determined, as in-between d′MIN1 and d′MIN2 on
When peaks and valleys which frame every particular pulse are identified, the energy of every pulse can be calculated. The energy of the pulse is mathematically a square of the sample points under the curve and is described by:
where a group of N charges qi at positions ri is considered. For each i value, Φ(ri) is the electrostatic potential due to all point charges.
It allows use of a complete pulse waveform information located in between two predetermined troughs, composing a single pulse. The method is an analogy of the calculation of electric potential energy E in electricity.
Calculation of an area under the pulse curve is based upon numerical integration using a quadrature approach, (in this particular implementation, however other methods may be used) i.e. summarising the integrated parts of the pulse. The sum of the integrals under the curve represent a total square or energy of the single pulse (converted later to beat volume units), as shown on
where xi is the (i−1)-st zero of P′(x)n−1; weights
xi≠0, 1; remainder
There is a systematic error in estimation of area under the curve due to the quadrature method itself, but it influences the results minimally due to the equal algorithm-based calibration. This error due to the Gauss-Lobatto quadrature is typically less than 1%. However, other techniques which have lower error range may provide better accuracy (e.g. Gaussian or Gauss-Kronrod quadratures).
To calculate the area under the individual pulse by the quadrature-based method, the non-pulsative square SDC is substracted from the total calculated square STOTAL.
The heart beat volume (HBV) and the heart rate (HR) determine the heart minute volume (HMV) or cardiac output (CO) as an important value for circulatory regulation:
HMV=HR·HBV
The HR value can be determined using the same optical sensor by processing of the pulse plethysmographic waveform either in frequency or in time domain dependent on the hardware specification to meet a continuous real-time operation mode. In temporal domain the pulse rate is usually extracted as quantity of the PPG-pulses per data buffer. The plethysmographic waveform can be converted to the frequency domain by the Fourier transform (or fast Fourier transform (FFT) technique). And the HR is identified as the fundamental frequency harmonic with the highest power energy in a power spectrum and subsequently converted to the beats/minute units.
Cardiac output can be monitored in two modes, relatively and absolute. In relative mode only the relative changes of the SI during the measuring period are considered. These outputs are specific to the current monitoring session and might be used for comparative purposes with another monitoring sessions only after taking into account as far as possible all the monitoring conditions and physiological events, if some present. The absolute values of the CO, i.e. the volume of blood being pumped by the heart in minute in L/min, may be estimated through matching of the SI values with terms of a predetermined empirical calibration curve which has been derived empirically from a large data set of monitored probands. Such a calibration curve might be obtained through measurements of the CO parameter using a thermodilution-technique. Thermodilution involves injecting a cold (<8° C.) or room-tempered (<24° C.) saline solution through a central, or peripheral, line into the proband's circulatory system. The blood volume pumped by a ventricle in a minute can then be calculated by analysing the downstream temperature changes using a modified Stewart-Hamilton equation. Another alternative method to estimate CO-values is to use complex equations, which combine the SI outputs with individual cardiovascular characteristics, such as impedance, compliance, status of the vessels etc. Another method to achieve an absolute CO measurement for a particular measurement session is to initially calibrate the current device against another device which provides an initial reference calibration value. Recalibration may be required at intervals in order to keep the current device within a specified error tolerance.
An advanced sensor clip design assuring a constant or minimal pressure is recommended. The aim of this is to reduce the influence of the clip pressure on the measurement due to compression of tissues and/or blood stasis due to shrinkage of the vessels. All limitations inherent in standard pulse oximetry are similarly applicable to this spectroscopic method.
In one embodiment it will be appreciated that the above pulse cardio spectroscopy is a non-invasive and painless technique. The method can be accordingly applied to a larger patient population with a risk for hemodynamic instability. No potentially harmful intravenous, venous or arterial injections are required, which might lead either to the organ malfunctions, or in other cases allergic reactions, e.g. anaphylaxis. The beat-to-beat basis of the method allows a real-time continuous monitoring assuring a prompt medical therapeutic response.
Referring to
Preferably, a highly vascularized tissue area close to the central circulations can be used (e.g. ear or neck region above carotid artery, for reflection mode). These locations on the human body provide good sites for assessment of blood flow related parameters. The blood flow to organs essential for sustaining life do not decline appreciably unless the arterial pressure falls below the autoregulatory range as a result of, for example, hypotension caused by hypovolemia or circulatory shock. In addition, physiological effects such as vasoconstriction, and vasodilatation of the vessels are minimized at main blood-carrying vessels such as the carotid artery. Thus, the measurement error due to the autoregulation which is prevalent in the case of the smaller vessels is minimized by nodal application of the optical sensor. Thus, locating the sensor in proximity to main blood-carrying vessels is advantageous to the peripheral monitoring mode.
The sensor may alternatively be applied at the periphery (e.g. finger), however in this case an autoregulatory compensation algorithm is preferred, in order to minimise the measurement error due to the potential effects of autoregulation. The autoregulation of the cardiovascular system results from the Frank-Starling mechanism, when the heart stroke volume responds to the contractility of the cardiac muscle. An effect of the autoregulation mechanism on the periphery of the body (e.g. upper extremities) might be a vascular dilatation or contraction of the peripheral vascular bed, which can have an influence on the cardiac output estimation at distal measuring site.
The autoregulatory compensation algorithm may include an estimation of the central parameters and dynamic mechanical properties of an individual vascular system. These are a central blood pressure, peripheral vascular status (elasticity of the vessels), or vasomotory regulation. The peripheral monitoring mode in comparison with central mode is more practical due to the possibility of usage of the transmission measuring principle and simplicity of application.
Referring to
The system of the invention may be arranged to provide an estimation of blood oxygen saturation, heart rate, cardiac output and/or blood haemoglobin level and derive from these measurements an estimation of total oxygen uptake.
The invention is not limited to the embodiments described but may be varied in construction and detail.
Number | Date | Country | |
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61541389 | Sep 2011 | US |