The present invention relates to the field of bio-signal measurements relating to the cardiovascular system.
Numerous studies have shown that arterial vascular stiffness is a predictor of cardiovascular risk and mortality, as it provides an indicator about the state of health of the arteries and allows the early identification of organ damage even if still clinically asymptomatic.
It is possible to estimate arterial stiffness in a non-invasive way by measuring the speed of the sphygmic wave or pulse (pulse wave velocity, PWV).
The PWV trend measurement is achieved by measuring the propagation time between two sites, typically the neck (carotid artery) and the thigh (femoral artery). Then, by considering the distance between the two measurement sites and dividing it by the pulse propagation time, the propagation speed (PWV) is obtained.
Although this parameter is considered relevant in the evaluation of cardiovascular risk, it is hardly taken into consideration due to the difficulty in carrying out the measurement and the post-processing time that this requires. According to the known art, the evaluation of PWV is performed off-line, that is to say a certain time after the acquisition of the signals relating to the pulse waves.
These signals are generated by a transducer, typically a pressure sensor placed in contact with the patient's skin near an artery to measure the propagation time of the heartbeat.
Current PWV parameter measurement tools have limitations, such as:
Furthermore, in some cases the signal acquisition procedure is laborious and highly dependent on the operator, with the well-founded risk of unreliability.
For all the devices currently on the market, in fact, a long acquisition is required until the pulse signals necessary to measure the PWV are stable for a certain predetermined time period. And only after the acquisition, the signals are processed, but in this phase, the medical operator cannot intervene to change the position of the transducers and, above all, does not have control of any oscillations in the PWV trend, intrinsically related to the state of the cardiovascular system. Therefore, if for example the signals have a low S/N ratio, then it is necessary to repeat, blindly, the acquisition procedure until the acquisition process is considered satisfactory.
To evaluate the transit time (PTT) elapsed between the propagation of the pulse wave from the carotid to the femoral arterial, it is necessary to extrapolate a point on both signals that allows to identify the exact passage.
Generally, the aim is to recognize the “foot” of the sphygmic wave for each heartbeat. This method is defined as the “intersecting tangent algorithm” and includes the following steps:
At present there are no known methods, which allow the above steps to be carried out in real time.
If not specifically excluded in the following detailed description, what is described in this chapter is to be considered as an integral part of the detailed description.
The purpose of the present invention is to provide a real-time monitoring system of the PWV trend.
The basic idea of the present invention is to obtain a passband-filtered digital signal from which to identify relative minima (event starter), which act as reference points, on the basis of which the unfiltered or high-pass filtered numeric signal is windowed for perform the detection of the foot of the sphygmic wave by means of the per se known algorithm of the intersecting tangent algorithm.
The digital signal is analyzed by means of sampling segments, little by little the sensors generate the relating electrical signals, being them analog or digital ones.
The width of the segments is preferably fixed and predetermined. However, it can be expected to adapt the width of the segments, as the algorithm synchronizes itself with the heart rate and the width stabilizes itself.
For clarity, “current segment” is defined as the last segment, in chronological order, acquired.
According to the present invention, the search for the foot of the sphygmic wave is performed in a sliding observation window of variable amplitude so that the entire sphygmic pulse is always contained in the observation window.
According to a first aspect of the invention, when an impulse is not completely contained in the current segment, the final portion of the current segment containing the initial portion of the incomplete impulse is attached to the “next/future current” segment. Advantageously, no sphygmic impulse is omitted due to lack of synchronism between the segmentation operation and the heart rate of the subject under investigation.
Thanks to the present invention, the signal acquisition process is self-synchronized with the patient's heart rate, allowing to perform a PWV analysis in real time and above all not operator-dependent.
According to a first preferred variant of the invention, when a pulse is not completely contained in the current segment, it is in any case analyzed in real time to search for relative minima and subsequently, the final portion of the current segment containing the initial part of the pulse is attached to the next current segment and only then the foot of the pulse is identified among the relative minima previously identified. According to a further preferred aspect of the invention, substantially real-time operations are performed on the available pulse portion, even if it is not possible to complete the algorithm of the intersecting tangent in the current segment as the entire sphygmic pulse is not yet available.
In addition, when the signal has many artifacts, the search for relative minima among the candidates of the wave foot, before attaching the available portion of the window to the next current segment, turns out to be more advantageous in terms of the quality of the signal to be analysed, in view of the distortions brought about by the filtering in the initial part of the segment.
According to a second preferred variant of the invention, the intersecting tangent algorithm is entirely executed only when the pulse is complete, that is, only after the segment portion containing an initial portion of the pulse is attached to the next current segment. Obviously, this variant provides for a faster calculation of the processing unit, but allows to avoid identifying the relative minima in the previously identified window.
Advantageously, the possibility of measuring the PWV trend in real time allows to considerably expand the possible applications to allow for drastically modifying the known diagnostic protocols.
More specifically, the present invention allows the operator to evaluate the quality of the acquisitions in real time, so as to be able to promptly intervene on the positioning of the sensors.
The claims describe preferred variants of the invention, forming an integral part of this description.
Further objects and advantages of the present invention will become clear from the following detailed description of an example of its embodiment (and its variants) and from the attached drawings given purely by way of non-limiting explanation, in which:
The same reference numbers and letters in the figures identify the same elements or components.
In the context of this description, the term “second” component does not imply the presence of a “first” component. These terms are in fact used as labels to improve clarity and should not be understood in a limiting way.
The elements and features illustrated in the various preferred embodiments, including the drawings, can be combined with each other without however departing from the scope of this application as described below.
With reference to
Electrocardiographic signals are absolutely not necessary when taking measurements at two acquisition sites using the aforementioned two sensors TS1 and TS2.
Conversely, electrocardiographic signals are essential only when a single tonometric sensor is used.
The purpose is to compare the time lag of two wave feet of the same heart pulse to determine the PWV.
It is worth noting that for the purposes of the present description the concept of heart impulse can be confused with the concept of sphygmic wave which depends on it.
According to the present invention, a time window of 1.5 seconds is considered, at least initially. This choice allows the comfortable observation of at least one cardiac event even in the case of bradycardic subjects, in fact 40 bpm corresponds to a heartbeat every 1.5 seconds.
Preferably, to obtain an acceptable resolution, a time resolution of 1.5 ms has been chosen, the sampling frequency of which corresponds to 680 Hz, which, in turn, corresponds to a multiple of the sampling frequency of the tonometric sensors, which are characterized for a sampling frequency of the order of 170 Hz; in this case it is therefore necessary to carry out a conversion of the sampling frequency, restoring the signals of the tonometric sensors to a frequency of 680 Hz.
With an observation period of 1.5 seconds, the samples amount to 1020. Therefore, vectors (arrays) of 1020 values are generated, including the last acquired is indicated with the label CS.
The segmentation of the signal acquired every 1.5 seconds is strictly preferential. As this time interval allows a convenient on-screen updating of the vascular parameter. However, it is necessary to underline how the same algorithm can also work with different temporal segmentations, up to having segments capable of containing a single cardiac pulse with the consequent updating of the PWV parameter at each pulse. In fact, the present invention is totally adaptable on the basis of parameters that can be set by the operator or on the basis of automatic adaptations.
In particular, in the case of updating the parameter every beat, it is foreseen that the segmentation of the signal is initially fixed, for example of 1.5 seconds as described above. After analyzing, for example, 10 seconds of signal with segments of pre-ordered amplitude, an average cardiac period is calculated:
Advantageously, in this way, the algorithm automatically synchronizes itself with the heart rate and the dynamic window thus becomes automatic.
According to the present invention, two contiguous segments are considered, indicated as a whole with the label DS, in particular, the current segment CS is considered on the right and the segment that precedes it on the left, assuming that the time axis is right oriented. Thus, vectors with 2040 samples are obtained, hereinafter referred to as “double segment” DS, as shown in
In the case of the first acquisition segment, to obtain the double segment, a virtually previous segment is added, with all values set to zero.
The signal contained in the double segment is preferably interpolated by means of a cubic spline to be sampled at 2040 Hz or higher.
Preferably, the third degree interpolating polynomial is chosen so as to ensure continuity of the second derivative order.
Subsequently, the signal is high pass filtered with a frequency sufficient to eliminate any offset between the pulses, for example 0.5 Hz. The cutoff frequency of 0.5 Hz has been selected because it is a frequency close enough to the zero frequency (continuous), but high enough to allow rapid processing of the signal being filtered, taking into account the scope of obtaining a real-time analysis of the signals.
Subsequently, the signal obtained is low-pass filtered with a frequency of 2 Hz to try to extract the basic pulsatile component of the sphygmic signals, in order to identify single cardiac events in the signal segment considered, without being misled by atypical events (artifacts) or noise. After filtering, the relative minima necessary to identify, at least approximately, the single cardiac events, contained in the double segment not filtered or only high-pass filtered, are identified.
These relative minima, hereinafter referred to as “event starter”, however, do not correspond to the foot P of the sphygmic wave necessary for the calculation of the PWV, nor do they have any bearing on the relative minimum MR immediately to the left of the tangent Tan as shown in
In other words, the identification of the event starter allows to scroll the observation window in the time trace acquired in order to observe an entire impulse at a time.
These event starters are in fact useful for determining the approximate period T between two consecutive cardiac impulses and are useful for identifying the relative minima among which MR will be identified, as the minimum value closest to the tangent Tan.
A first observation window W is constructed, as indicated in
It is worth pointing out that in
However, it is preferred to perform the windowing and identification of the foot of the sphygmic wave on the high pass filtered signal, as the offset introduces instability in the analysis, although it is not excluded that this instability can be eliminated with other techniques other than high-pass filtering.
This window extends to the left of the dashed vertical line for a left sub-interval T/X, which can be a reasonably small fraction of T, which can vary between T/10 and T/3. It could also have a fixed width, but it is not recommended. The right sub-interval T/Y is wider than the left one because it is intended to reasonably include the wave front P on which to identify the tangent according to the intersecting tangent algorithm. It can be between 2T/3 and T.
Advantageously, the observation window W has an amplitude that depends on the cardiac period T, adapting itself to the signals generated by the patient under investigation.
According to the invention, attention is focused essentially on the current segment CS, that is, on the right segment of each double segment DS, as the relative samples are acquired.
Two conditions can occur:
In the first case it is possible to immediately identify the point MD, the tangent Tan and the minimum point immediately preceding (on the left) of the tangent, etc.
In the second case, you can proceed in two different ways.
According to a first preferred variant of the invention, the DT portion of the window W is attached to the next current segment CS and the pulse foot is identified.
According to a second variant, it is checked whether there are the conditions for carrying out pre-processing.
More specifically, with reference to
Although this sub-interval is insufficient to complete the identification of the pulse foot, it is useful for identifying the relative minima, in the non-filtered or only high-pass filtered signal, among which the impulse foot will be identified later.
Also in this case the portion DT of W available is attached to the next current segment CS, but having already stored in a buffer the most probable minima among which the pulse foot is selected later.
This fact makes the present analysis system as contemporary as possible to the acquisition of signals.
If the event starter is very close to the end of the current segment, see
In other words, the step of searching for the relative minima and the step of attaching the portion DT to CS can be inverted in terms of the listing order of execution in relation to the circumstances.
This allows for an observation window that flows “smoothly” over time, although the acquisition of signals occurs in discrete segments.
In other words, the solution shown by the diagram in
The observation window can be equal to the period or it can be reduced slightly for example equal to ¾T, therefore the observation window can be confused with the period bearing in mind that between them there is a proportionality such that the window has amplitude between ¾ of the period T and the whole period T.
Once the feet of the corresponding sphygmic waves in the two measurement sites have been identified for the same cardiac pulse, the relative time lag and the parameter PWV are calculated in a known way.
Although the search and storage of a certain number of minima can increase the computation load, compared to the case in which the minimum MR is searched from right to left, this allows to make the analysis fast and simultaneously with the acquisition of new samples, allowing the updating of the information on the screen almost simultaneously with the acquisition of the new segments.
For the purposes of this description it must be clear that an analysis leading to an update every 3 seconds would still be considered in real time, as it would still allow the doctor to immediately detect an incorrect positioning of the sensors.
Some particularly important implementation details are now described.
Obout the Stability of the Measures
According to another aspect of the present invention, the percentage standard deviation is evaluated on the last 10 values of the PWV parameter and when this is less than 5% then the PWV parameter is more stable. In other words, the standard deviation allows the operator to evaluate the correctness of the PWV measurement in real time. When this standard deviation value is greater, it is the operator's responsibility to accept the current PWV value or intervene, for example, on the repositioning of the sensors.
Another parameter that is believed to ensure greater reliability of the measurements is the signal-to-noise ratio of the signals acquired by the sensors. According to a preferred variant of the invention, the system comprises a device on which the signals acquired by the sensors are shown. These signals are zoomed only when the peak-to-peak amplitude of the extrapolated pulse waves is greater than a certain threshold to indicate greater reliability of the signal acquisition and therefore of the PWV calculation.
According to another aspect of the present invention, a report is generated containing all the values of the differential propagation times PTT between the two sites and the corresponding PWV values in addition to the final PWV value, which is obtained as an average on the PWV values whose corresponding PTTs result within an interval centered on the average value of the PTT extracted over a predetermined time window. Preferably, this time window is selected on the basis of a relative greater stability of the measurements as described above.
One of the problems that had to be faced in the realization of the present invention is the filtering of the signal acquired by means of the tonometric sensors.
To ensure that there is no distortion on the high pass filtered signal a fourth order biquadratic filter has been devised, shown with the help of
y[n]=b0*x[n]+d1
d1=b1*x[n]+a1*y[n]+d2
d2=b2*x[n]+a2*y[n]
More specifically, according to this preferred method of signal filtering, the signal undergoes the following steps:
Both the first filtering and the second filtering operate in the same way in the sense that if it is intended to filter high pass the coefficients a1, a2, b1, b2 are chosen by the person skilled in the art in order to obtain a high pass filtering. The same criterion applies in the case of low pass filtering. Obviously, it is known to those skilled in the art that band-pass filtering can be obtained by first operating a high-pass (or low-pass) filtering and subsequently a low-pass (or high-pass) filtering.
The double inversion with the two intermediate filtering stages ensures the zeroing of any distortion introduced by the filtering operation.
This method is useful in any situation it is necessary to filter both low-pass and high-pass a signal sampled with short-length segments.
Indeed, the fact of considering double segments guarantees two relevant aspects:
It was found that the identification of event starts is particularly reliable when this filtering technique is used.
Then taking into account that the identification of event starts allows to narrow down the analysis of the signal in order to identify
The present invention can be advantageously implemented by means of a computer program, which comprises coding means for carrying out one or more steps of the method, when this program is executed on a computer. Therefore, it is intended that the scope of protection extends to said computer program and further to computer readable means comprising a recorded message, said computer readable means comprising program coding means for carrying out one or more steps of the method., when said program is run on a computer.
Implementation variants of the described non-limiting example are possible, without however departing from the scope of protection of the present invention, including all the equivalent embodiments for a person skilled in the art, to the content of the claims.
From the above description, the person skilled in the art is able to realize the object of the invention without introducing further construction details.
Number | Date | Country | Kind |
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102020000027846 | Nov 2020 | IT | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/060508 | 11/12/2021 | WO |