The present invention relates generally to signal analysis, and specifically to analysis of signals generated by a beating heart.
One of the methods for characterizing cardiac activity relies on analyzing electrical signals generated by a heart as the heart beats. The signals typically have a relatively low level, of the order of millivolts, so that accurate analysis of the signals may be difficult. Notwithstanding the difficulties, accurate analysis can lead to improved characterization of heart activity, including determination of regions of the heart which may be defective.
Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated documents in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.
An embodiment of the present invention provides a method for characterizing an electrocardiogram, including:
receiving a first unipolar signal from a first location of a heart and a second unipolar signal from a second location of the heart;
generating a bipolar signal from the first and second unipolar signals;
analyzing the bipolar signal to delineate a time period during which the first and second locations generate a bipolar complex; and
analyzing the first unipolar signal within the time period to determine an activation time of the first location.
Typically, analyzing the bipolar signal includes determining search window bounds to be applied to the bipolar signal. Analyzing the first unipolar signal may include applying the search window bounds to the first unipolar signal.
In a disclosed embodiment delineating the time period includes feeding data of the bipolar signal into a two-state state machine so as to determine bounds of the time period.
In a further disclosed embodiment analyzing the bipolar signal includes sorting data of the bipolar signal to determine a threshold level for the bipolar complex.
In a yet further disclosed embodiment analyzing the bipolar signal includes differentiating then rectifying data of the bipolar signal, so as to generate differentiated data. Delineating the time period may include feeding the differentiated data into a four-state state machine so as to determine bounds of the time period. Determining the activation time may include forming a first derivative of the first unipolar signal, and assigning a unipolar onset activation time as a time instant wherein the first derivative is a minimum value.
In an alternative embodiment the activation time includes a first activation time, and the method further includes analyzing the second unipolar signal within the time period to determine a second activation time of the second location.
In a further alternative embodiment the bipolar complex includes a first bipolar complex and a second bipolar complex, and the time period includes a first time period during which the first bipolar complex is generated and a second time period during which the second bipolar complex is generated, and analyzing the first unipolar signal includes determining first and second activation times respectively within the first and second time periods.
There is further provided, according to an embodiment of the present invention, apparatus for characterizing an electrocardiogram, including:
a probe which is configured to receive a first unipolar signal from a first location of a heart and a second unipolar signal from a second location of the heart; and
a processor which is configured to:
generate a bipolar signal from the first and second unipolar signals,
analyze the bipolar signal to delineate a time period during which the first and second locations generate a bipolar complex, and
analyze the first unipolar signal within the time period to determine an activation time of the first location.
There is further provided, according to an embodiment of the present invention, a computer software product for characterizing an electrocardiogram, including a tangible computer-readable medium in which computer program instructions are stored, which instructions, when read by a computer, cause the computer to:
receive a first unipolar signal from a first location of a heart and a second unipolar signal from a second location of the heart;
generate a bipolar signal from the first and second unipolar signals;
analyze the bipolar signal to delineate a time period during which the first and second locations generate a bipolar complex; and
analyze the first unipolar signal within the time period to determine an activation time of the first location.
The present disclosure will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings, in which:
An embodiment of the present invention provides a method for characterizing an electrocardiogram, by processing electrocardiogram data in two stages. The data is in the form of two unipolar signals from two different locations in the heart, and the characterization is able to determine activation times of locations in the heart providing the data.
In a first stage of the process, the data is analyzed as a bipolar signal, to determine time instances of the signal that delineate a bipolar complex within signal. In a second stage of the process, the time instances are used as bounds within which each of the unipolar signals may be separately analyzed.
In order to determine the activation times of the different locations, a first derivative of each of the unipolar signals is evaluated. The time at which the first derivative is a minimum is assumed to be an onset activation time, i.e., the time at which tissue generating the unipolar signal begins to activate. The method may be used to find the onset activation times of each of the two different locations.
The method may be used to analyze signals which have one bipolar complex per heart beat, and may also be used to analyze signals having more than one bipolar complex per heart beat.
The inventors have operated the method in real time, and have clinically verified that the method provides accurate results.
Reference is now made to
Typically, probe 14 comprises a catheter which is inserted into the body of a subject 16 during the investigative procedure. A distal tip 18 of the probe comprises a first electrode 20 and a second electrode 21 which receive electrocardiograph (ECG) signals from respective locations 23 and 25 in heart 12. The locations are typically within tissue 27 of the heart. The signals from the two electrodes form a bipolar signal which is analyzed by system 10, as described herein. The investigative procedure is performed by a user 22 of system 10, and in the description herein user 22 is assumed, by way of example, to be a medical professional.
One or more other electrodes 29 are used during the procedure. The other electrodes may be attached to probe 14, to another probe similar to probe 14 and located within the heart, and/or to the skin of subject 16. The other electrodes are used as reference electrodes to provide a reference ground for the signals from electrodes 20 and 21, in which case the two signals of the respective electrodes are unipolar signals.
System 10 is typically controlled by a system processor 24 which may be realized as a general purpose computer. The system processor comprises a processing unit 26 communicating with a memory 28. Processor 24 may be mounted in a console 30, comprising operating controls 32 that typically include a keypad and a pointing device such as a mouse or trackball that professional 22 uses to interact with the processor. Results of the operations performed by processor 24 are provided to the professional on a screen 34 which may display a diagram of the results of the analysis performed by the system. Alternatively or additionally, the results are used by system 10 in presenting other parameters to professional 22, such as a map of local activation times (LATs) of heart 12. Professional 22 is able to use controls 32 to input values of parameters used by processor 24 in the operation of system 10
Processor 24 uses software stored in memory 28 to operate system 10. The software may be downloaded to processor 24 in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible computer-readable media, such as magnetic, optical, or electronic memory.
System 10 can be realized as the CARTO XP EP Navigation and Ablation System, available from Biosense Webster, Inc., 3333 Diamond Canyon Road, Diamond Bar, Calif. 91765, suitably modified to execute the procedures described herein.
In some cases electrodes 20 and/or 21 may provide both ECG and other signals or the electrodes may be used for other purposes. For example, the CARTO system referenced above uses electrodes which detect ECG signals, measures impedances of the electrodes for tracking, as well as using the electrodes to provide radio-frequency ablation.
The bipolar complex is bounded by an initial time instance TONSET and a final time instance TTERMINATION. The processor uses the time bounds of the bipolar complex to define a window within which to perform unipolar analysis.
In a unipolar stage 74, the processor considers each of the electrode 20 and 21 signals separately, as unipolar voltage vs. time signals, and analyzes the unipolar signals within the time window found in the bipolar stage. The analysis enables the processor to determine respective unipolar activation times at which the regions in contact with electrodes 20 and 21 activate. The activation times typically comprise times at which the derivative of the unipolar signal has a maximum negative value.
Bipolar stage 72 is formed of three modules: a search window module 76, and two subsequent modules, a first phase module 78 and a second phase module 80. The operations performed by the processor for each module are described below. In the description the signals from electrodes 20 and 21 are assumed to be sampled over a period of approximately 2.5 s at a rate of approximately 1 kHz, giving approximately 2,500 samples to be analyzed by system 10. However, system 10 may operate with any convenient sample period and rate of sampling.
In an RR interval block 92 the processor finds the mean time periods
In a search window parameters block 94 the processor calculates times of a start and end times SWSTART, SWEND, of a search window to be used in further analysis of the input data. In the CARTO system referenced above, professional 22 is able to program a window of interest (WOI) center time and width, WOICENTER, WOIWIDTH. In order to perform the calculation in the CARTO system, block 94 uses values of parameters WOICENTER, WOIWIDTH, together with an additional time period WOIDELTA, also referred to herein using the symbol A, provided by professional 22. WOICENTER is typically arbitrarily set by the professional to approximate an expected half-way point in time of mean time period
It will be understood that while the calculation of the start and end times of the search window generated by block 94 has been explained with reference to the CARTO system, professional 22 may use any convenient method known in the art to delineate an appropriate search window.
A typical value for Δ is approximately 20 ms. A typical value of
The filtered smoothed data is then windowed, using the search window times SWSTART and SWEND from block 94 (
In a sort block 122 the smoothed samples are sorted by value and arranged into a frequency distribution. From the frequency distribution a threshold voltage level THR, that is to be applied in analyzing the data, is extracted. Level THR is selected to be close to, but above, the level of the smoothed baseline data. In one embodiment, the level is selected as a base value corresponding to the 5th percentile of the frequency distribution, added with a factor of 5% of the amplitude of the smoothed signal. Alternatively, level THR may be selected by any other suitable method for defining a level close to, but above, the smoothed baseline data.
In addition, sort block 122 determines a peak sample X(np1) of the smoothed data.
The processor supplies level THR, and the sampled smoothed values X(n) to a two-state state machine 124. Conditions for transitions between the two states A and B of the state machine are indicated in
The data from block 154 is windowed in a window block 156, using the search window times SWSTART and SWEND from block 94 (
The set of differentiated smooth data transfers to a sort block 158, as well as to a four-state state machine 160 in second phase 80 of the bipolar stage (
Sort block 158 also determines a peak value D(np2) and an index np2 of the differentiated binary complex, and transfers D(np2) to the four-state state machine.
In the state machine, parameters cnt and gcnt count the number of samples operated on by the state machine. Variables CNTSTATE2, CNTSTATE3, and CNTSTATE4 may be set by professional 22, as representative of acceptable numbers of samples between states of the state machine as transitions occur through the differentiated noise level NOISE. Typical values of CNTSTATE2, CNTSTATE3, and CNTSTATE4 are respectively 8, 18, and 4, but the values may be set by professional 22 to any suitable value.
A graph 172 shows the states of the state machine, and the transitions between the states, in determining the value of TONSET. As shown in the graph, processor 24 (
From the values of TONSET and TTERMINATION system 10 is able to evaluate a signal-to-noise ratio (SNR) of the bipolar complex, according to equation (1):
where S is the root mean square (RMS) value of the unfiltered bipolar data lying between TONSET and TTERMINATION, and
N is the RMS value of the unfiltered bipolar data before TONSET and after TTERMINATION.
Professional 22 is able to use the value of SNR in order to establish a confidence level for the evaluated values of TONSET and TTERMINATION.
Returning to
For each signal the processor selects the time at which the first derivative
has its most negative, i.e., its minimum, value, and this time is assumed to be the time at which the tissue generating the signal begins to activate.
For clarity, the description above considers embodiments of system 10 that evaluate signal parameters where there is one bipolar complex per heart beat. System 10 is not limited to such evaluations, and may be used to identify signals where multiple bipolar complexes occur per heart beat, and furthermore, to evaluate signal parameters of the multiple bipolar complexes. The identification of the occurrence of multiple bipolar signals may typically be by measuring intervals between adjacent complexes, since, in contrast to signals having one bipolar complex per heart beat, the intervals change. Those having ordinary skill in the art will be able to adapt the description above, mutatis mutandis, to evaluate parameters of unipolar signals generating multiple bipolar complexes occur per heart beat. Such parameters include, but are not limited to, evaluating respective unipolar onset activation times for each bipolar complex in a given heart beat.
A graph 200 (
A graph 210 (
System 10 may also be used to evaluate other parameters relevant to signals having multiple bipolar complexes occurring within one heart beat, as will be apparent to those of ordinary skill in the art. Such parameters include, but are not limited to, a duration time between first and second atrial bipolar complexes, by measuring a mean RR interval between the complexes. All such parameters are assumed to be included within the scope of the present invention.
Steps 252-260 are actions performed in bipolar stage 72 and step 262 is performed in unipolar stage 74 (
In an initial step 252, the processor receives signals as sampled data from electrodes 20 and 21. The processor analyzes the signals to identify R waves, an
In a first filtration step 254, the sampled data are rectified, filtered, and windowed, and the resulting smoothed data is fed into two-state state machine 124. In a demarcation step 256 the two-state state machine divides the data it receives into baseline sections and a bipolar complex section. Steps 254 and 256 are as described above with reference to
In a second filtration step 258, the sampled data of the bipolar complex are filtered, differentiated and windowed to derive a second smoothed signal, as described above with reference to
In a bipolar complex analysis step 260, the processor evaluates onset and termination times of the complex by feeding the second smoothed signal data into four-state state machine 160, as described with reference to
In an activation time step 262, a time of activation of tissue in contact with electrodes 20 and 21 is determined by analyzing the unipolar signals from each electrode within a window defined by the bipolar onset and termination times of step 260. Actions performed by the processor in step 262 are described with reference to
The analysis differentiates the unipolar signals within the window, and finds the respective times at which the first derivatives are most negative, i.e., are minima. These times correspond to an onset activation time of the tissue in contact with electrode 20, and an onset activation time of the tissue in contact with electrode 21.
It will be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.
Number | Date | Country | |
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20180140212 A1 | May 2018 | US |
Number | Date | Country | |
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Parent | 13453249 | Apr 2012 | US |
Child | 15355275 | US |