Method and system for estimating residual ECG noise level and adaptive noise threshold - Patents.com

Abstract

To provide a more simplified, accurate and real-time approach for noise estimation in ECG signals.SOLUTION: A system including means for estimating the residual noise level in electrocardiogram (ECG) signals is disclosed. The disclosed system and methods may be used in electrocardiograph devices. According to an exemplary embodiment of the present invention, a plurality of electrodes positioned in proximity to a cardiac structure may measure an electrical signal of the cardiac structure to produce the ECG signal. The system may segment the ECG signal into a plurality of segments. For each of the segments, the linear trend energy and / or direct current (DC) energy may be removed from the segment, and the estimated noise energy of the segment may be calculated. A subset of the plurality of segments with a minimum estimated noise energy may be selected. The residual noise energy of the ECG signal may be estimated by calculating an average of the estimated noise energy over the subset of segments.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates generally to systems and methods for estimating noise levels in electrical signals, and more particularly to systems and methods for estimating noise levels in electrocardiogram (ECG) signals and adaptive noise threshold algorithms. [Background technology]

[0002] Electrocardiography is the measurement and recording of the electrical activity of the heart over a period of time using electrodes placed on the skin and / or inside the heart using a catheter. These electrodes detect small electrical changes resulting from the electrophysiological pattern of depolarization of the myocardium during each heartbeat and can therefore be used to detect cardiac abnormalities such as myocardial infarction, pulmonary embolism, organic heart disease (e.g., heart murmurs), tachycardia, or cardiac arrhythmias (e.g., atrial fibrillation). Electrocardiography may be performed with an electrocardiograph, but subsequent testing produces an electrocardiogram (abbreviated EKG or ECG, but both mean the same thing), which shows the electrical signals in the heart, typically as a graph of voltages that represent the electrical activity of the heart over time.

[0003] During each heartbeat, a healthy heart undergoes a regular progression of depolarization. This regular pattern of depolarization gives rise to a characteristic ECG tracing. A trained physician can obtain a great deal of information about the structure of the heart and the function of its electrical conduction system by looking at the morphology of the ECG signal. Among other things, the ECG can be used to measure the rate and rhythm of the heartbeat, the size and location of the heart chambers, the presence of damage to the heart's muscle cells or conduction system, the effects of cardiac drugs, and the function of implanted pacemakers. Interpretation of the ECG is fundamentally about understanding the cardiac electrical conduction system. Normal conduction initiates and propagates in a predictable pattern, and deviations from this pattern may be normal variations or due to disease. Thus, the presence of noise in the ECG signal can hinder the ability to effectively analyze the heart's activity. Furthermore, many algorithms and systems, including cardiac 3D imaging and ablation systems (e.g., the CARTO® system), rely on the ECG signal for referencing, mapping, and analysis. To improve the way such systems and algorithms function, an accurate and real-time estimation of the actual residual noise level in the ECG signal is needed.

[0004] Electrocardiogram signals contain unwanted noise, which may include low frequency noise (e.g., due to respiration and / or baseline drift) and higher frequency noise, such as power supply noise and / or deflection noise. Filters (e.g., power filters) may be used to remove noise of certain frequencies. However, filters may not effectively remove all noise (e.g., noise at frequencies outside the filter bandwidth). Thus, there is usually residual noise in the ECG signal even after filtering. Estimating the residual noise is important for various reasons, such as monitoring system performance and adapting various algorithms. ECG noise estimation methods are challenged by the simultaneous presence of signal and noise. Thus, approaches to noise estimation may include, as a first step, attempting to separate the desired signal and the noise signal. Existing methods for separating these signals tend to be very complex. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need for a simpler, more accurate and real-time approach for noise estimation of ECG signals that can be used to assess and manage noise levels in systems that rely on ECG. [Means for solving the problem]

[0006] A system is disclosed that includes means for estimating a residual noise level in an electrocardiogram (ECG) signal. The disclosed system and method may be used in an electrocardiogram device. According to an exemplary embodiment of the present invention, a plurality of electrodes positioned proximate to a cardiac structure may measure an electrical signal of the cardiac structure to generate an ECG signal. The system may segment the ECG signal into a plurality of segments. For each of the plurality of segments, a trend including a constant direct current (DC), a linear trend, and / or an interpolated low frequency trend may be removed from the segment, and an estimated noise energy of the segment may be calculated. A subset of the plurality of segments having a minimum estimated noise energy may be selected. The residual noise energy of the ECG signal may be estimated by calculating an average of the estimated noise energy over the subset of segments. The estimated noise energy may be used in various applications, for example, to compare and select diagnostic equipment (e.g., catheters, electrodes) having the minimum noise, to detect and warn errors in the equipment for troubleshooting, and to adjust system performance and system thresholds / algorithms utilizing the estimated noise in the system. [Brief description of the drawings]

[0007] The above and other features and advantages of the present disclosure will become apparent from the following more particular description of preferred embodiments of the present disclosure, as illustrated in the accompanying drawings. [Figure 1] 1 is a schematic diagram of an exemplary electrocardiogram device 100, according to an exemplary embodiment. [Diagram 2] 4 is a flowchart of an exemplary procedure for estimating a noise level in an electrocardiogram (ECG) signal, according to an exemplary embodiment. [Figure 3A] 1 shows exemplary ECG noise levels at different levels for an ECG signal generated using a first type of catheter of the CARTO system, where the ECG signal is shown in raw form (digital output), after power noise filtering, and after user selectable filtering (by the CARTO system). [Figure 3B] 1 shows exemplary ECG noise levels at different levels for an ECG signal generated using a second type of catheter of the CARTO system, where the ECG signal is shown in raw form (digital output), after power noise filtering, and after user selectable filtering (by the CARTO system). [Figure 3C] 3 shows an exemplary 1 second ECG signal in raw format generated using a first type catheter of the CARTO system, showing an exemplary segment used to calculate a residual ECG noise level estimate according to the procedure shown in FIG. 2. [Figure 3D] 3 shows an exemplary 1 second ECG signal in raw format generated using a second type of catheter in the CARTO system, showing an exemplary segment used to calculate a residual ECG noise level estimate according to the procedure shown in FIG. 2. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] An exemplary electrocardiogram system may include multiple leads (e.g., 12 leads, or fewer or more) and multiple electrodes (e.g., 10 electrodes, or more) placed on the patient's limbs and on the surface of the chest. The overall magnitude of the cardiac electrical potential is measured from the leads, each corresponding to a different measurement angle, and recorded over a period of time. For example, an electrocardiogram performed with intracardiac electrodes attached to a catheter placed in a heart chamber produces an ECG called an intracardiac electrocardiogram (ICEG), and may be used in combination with or instead of leads placed on the patient's external surface. A lead consisting of two electrodes of opposite polarity is called a bipolar lead. A lead consisting of a single positive electrode and a reference point is a unipolar lead.

[0009] To measure cardiac electrical activity, the ECG electrodes must be able to detect very small changes in electrical potential energy in the patient's skin or cardiac tissue, for example electrical changes that can be detected by the ECG electrodes as cardiac electrical signals measured at around 1 millivolt (mV) or less.

[0010] In conventional intracardiac electrocardiogram systems, ECG electrodes in contact with the skin and / or cardiac tissue measure cardiac signal current flowing toward the electrodes as a positive charge and cardiac signal current flowing away from the electrodes as a negative charge to generate a voltage reading of the heart's electrical signal over time. The goal of an electrocardiogram system is to minimize artifacts and maximize the accuracy of the EKG signal to provide reliable information to physicians. ECG signals generated by electrocardiogram systems are widely used in diagnosing and monitoring cardiac conditions, and they are sensitive to a variety of mixed noises, which can reduce diagnostic accuracy and can also hinder a physician's ability to effectively diagnose and treat cardiac conditions.

[0011] According to an exemplary embodiment of the present invention, the disclosed electrocardiogram system and method estimates the residual noise level in an ECG signal, including a body surface or intracardiac ECG signal, using a dynamic and real-time residual noise estimation procedure. Additionally, the disclosed residual noise estimation procedure of the present invention may be used with other forms of signals, such as neural recordings, electrical signals over communication lines, and any other electrical signals where the desired and noise signals need to be separated in time, including signals generated in non-biomedical applications. According to an exemplary embodiment of the present invention, in the residual noise estimation procedure, the ECG signal may be assumed to include short sections and to be free of local or far-field activity. According to an exemplary noise estimation procedure, the ECG signal is segmented into short segments (e.g., 40-50 millisecond windows). Direct current (DC) components, linear trend components, and / or any low-pass components are removed from the ECG segments, and the energy of each ECG segment is calculated (e.g., by calculating the root mean square or peak-to-peak amplitude). The RMS non-DC, non-trending energy of the ECG segment is then determined and used as an estimate of the noise level of the ECG signal. The invention takes advantage of the property that noise energy levels do not usually change rapidly (except perhaps in the case of temporary communication noise), and further details of the invention are described below.

[0012] 1 is a schematic diagram of an exemplary electrocardiogram device 100, according to an exemplary embodiment. The electrocardiogram device 100 may include, but is not limited to, any of the following components: a console system 101, an intracardiac lead 107 connected to a catheter 120 having a distal end 114 inserted into a heart 126 of a patient 105, a non-contact electrode 116 located at the distal end 114 of the catheter 120, and a lead 110 connected to electrodes 112 positioned at various locations on the skin of the patient 105. The console system 101 may include, but is not limited to, any of the following components: an analog-to-digital converter (ADC or A / D converter) 125, a processor 130, a data storage device 155, a data port printer 160, an input / output (I / O) device 165, a visual display device 170, and / or an energy source device 175. Processing unit 130 may include, but is not limited to, any one or more of the following components: video controller 135, digital signal processor (DSP) 140, microprocessor 145, and / or microcontroller 150.

[0013] Catheter 120, leads 107 and 110, electrodes 112 and 116, and / or other non-illustrated components of electrocardiogram device 100 (e.g., additional catheters, sensors, transformers, etc.) may be used directly on, within, and / or in proximity to patient 105 to gather information for use in visualization, diagnosis, and treatment (e.g., ablation therapy). This information may be provided to console system 101 for processing, visualization, and operator control and direction, some of which are described below.

[0014] A series of leads 110 and intracardiac leads 107 connect electrodes 112 on the skin surface of the patient 105 and electrodes 116 on a catheter 120 within the heart 126 to the main console 101 of the electrocardiogram machine 100. In one example, the intracardiac catheter 120 may be used for diagnostic and / or therapeutic procedures, such as for mapping electrical potentials within the heart 126 of the patient 105. In some examples, the leads may be bipolar or unipolar. In one example, the catheter 120 may be inserted into the vascular system of the patient 105 such that a distal end 114 of the catheter 120 enters a chamber of the heart 126 of the patient 105. Although FIG. 1 shows a single catheter 120 and intracardiac lead 107, additional catheters and leads, not shown, having one or more electrodes and / or sensors may be used as well. Additionally, the electrocardiogram device 100 may use only the surface electrodes 112, only the intracardiac electrodes 116, or both the surface electrodes 112 and the intracardiac electrodes 116 for ECG readings.

[0015] A raw ECG signal 115 (i.e., an analog input signal) is obtained from one (or more) of the electrodes 112 and / or 116 and converted from analog to digital form by an adjustable gain ADC 125. The ADC 125 samples the analog input signal 115 at a sampling rate to generate and provide a digital output 117 of the ECG signal 115. The resolution of the ADC 125 indicates the number of discrete values ​​that the ADC 125 can generate over a range of analog values ​​and can be defined electrically in units of volts. The number of voltage intervals that the ADC 125 can generate is 2 M where M is the resolution of the ADC in bits.

[0016] Once the analog signal has been converted, the ADC 125 communicates the digital ECG signal to a processing unit 130 to generate an ECG graph and / or perform other ECG analysis. The processing unit 130 is coupled to a data storage device 155, a data port and printer 160, other I / O devices 165, and a visual display 170, which may be used to display the ECG generated by the ECG machine 100. The ECG machine 100 and / or any of the components therein may be powered by one or more energy sources 175.

[0017] Data storage device 155 is any device that records information. The data storage device may provide a storage medium for the signals included in device 100, as well as provide a location for the processing unit 130 calculations to be stored.

[0018] Microprocessor 145 may be a computer processor that incorporates the functionality of a computer's central processing unit (CPU) onto one integrated circuit (IC) or onto several integrated circuits. Microprocessor 145 may be a general-purpose clocked, register-based programmable electronic device that accepts digital or binary data as input, processes it according to instructions stored in memory or data storage device 155, and provides results as output. Microprocessor 145 includes both combinatorial and sequential digital logic.

[0019] Microcontroller 150 can be one or more small computers on a single integrated circuit. Microcontroller 150 can include one or more CPUs along with memory and programmable input / output peripherals. Program memory and a small amount of RAM in the form of ferroelectric RAM, NOR flash, or OTP ROM are often also included on the chip. Microcontrollers are designed for embedded applications, as opposed to microprocessors used in personal computers or other general purpose applications, which are made up of a variety of discrete chips.

[0020] The DSP 140 can perform digital signal processing to perform various signal processing operations. A signal processed in this manner is a series of numerical values ​​representing samples of a continuous variable in a domain such as time, space, or frequency. Digital signal processing can involve linear or nonlinear operations. Nonlinear signal processing is closely related to nonlinear system identification and can be performed in time, frequency, and space-time domains. The application of digital computing to signal processing allows many advantages over analog processing in many applications such as error detection and correction in transmission, and data compression. DSPs can be applied to both streaming and static (stored) data.

[0021] 2 is a flow chart of an exemplary residual ECG noise level estimation procedure 200, in accordance with an exemplary embodiment of the present invention. The exemplary residual ECG noise level estimation procedure 200 may be implemented, for example, in an electrocardiogram system, such as the exemplary electrocardiogram device 100 of FIG. 1. For example, the residual ECG noise level estimation procedure 200 may be implemented in the processor 130 and may use the unprocessed ECG signal 115.

[0022] In step 202 of the residual ECG noise level estimation procedure 200 shown in FIG. 2, the ECG data is segmented into multiple overlapping segments or windows. According to an exemplary embodiment, the ECG data may be a raw ECG signal (e.g., a unipolar or bipolar ECG signal) generated by one or more electrodes located in or near the patient's heart before any noise filtering (e.g., power filtering). The procedure 200 may be performed on various versions of the ECG signal (i.e., before / after various processing stages). According to an exemplary embodiment, the ECG data may be a raw analog ECG signal before or after power filtering, or the ECG data may be a processed (e.g., CARTO) ECG signal after power filtering, high-pass filtering, and / or low-pass filtering. For example, performing the procedure 200 on a raw analog signal before power filtering allows detection of the actual noise level introduced by the catheter / electrodes, which may be hidden by filtering. Additionally, in a clinical setting, other sources of noise may be introduced that the power filter is not designed to remove and / or the power filter may introduce other problems or cause errors. In another example, procedure 200 may be performed after power filtering, e.g., to estimate the effectiveness of the filtering and / or to use the resulting residual noise level estimate as a dynamic (over time) noise level estimate in systems and algorithms that take noise levels into account and / or to report the resulting residual noise level estimate to a monitoring station (user) for use, e.g., for correction, analysis, and / or big data.

[0023] The duration of the segments may be selected to separate energy fluctuations due to undesired noise from non-DC or trend energy due to the atrial / ventricular signals of interest (e.g., slope effects in the signal). In particular, the segments may be selected to be short enough so that non-DC trend energy is minimized. For example, most tachycardias (apart from perhaps atrial fibrillation) include long periods that do not include atrial / ventricular signals, and therefore short segments within those periods may include minimal or no trend energy. In one example, segments of about 40 ms to 50 ms in duration may be selected for a unipolar ECG signal of 1 second duration. Exemplary segments are for a 1 second ECG signal and are shown in FIGS. 3C and 3D. According to an exemplary embodiment, adjacent segments in the multiple segments may overlap in time. For example, the overlap between adjacent segments may be about 10% or less of the segment duration (e.g., 5 ms overlap for a 50 ms segment). According to other exemplary embodiments, the segments may be non-overlapping, may be adjacent, or regularly spaced intervals may be selected.

[0024] For each of the multiple ECG segments, one or more of the following steps (i.e., steps 204, 206, and / or 208) may be performed. In step 204 of the residual ECG noise level estimation procedure 200 shown in FIG. 2, a linear trend energy is determined and removed from the ECG segment. The linear trend energy corresponding to an increase or decrease in the slope of the ECG segment may be determined, for example, using linear regression techniques. Examples of trend energy include sharp slopes or spikes in the ECG signal, such as the spikes near or around 0.1 seconds and 0.6 seconds in FIGS. 3C and 3D.

[0025] In one example, the linear trend energy may be determined using regression analysis to find an equation (e.g., of the form Y=μΧ+β) that fits a straight line (i.e., linear) trend of the data in the ECG segment. Once the linear trend energy is determined, it may be subtracted from the ECG segment to remove the linear trend energy. In some cases, the linear trend energy may be minimal or nonexistent within a short ECG segment (even if the trend exists over a time window longer than the segment, e.g., the entire duration of the measured signal). Thus, in such cases, step 204 may be omitted.

[0026] In step 206 of the residual ECG noise level estimation procedure 200 shown in Figure 2, DC energy and / or low pass energy components are removed from the ECG segment. The DC energy (and any low pass energy components), also referred to as the DC bias, DC component, DC offset, or DC coefficient, is determined and calculated as the average amplitude of the waveform of the ECG segment, which may then be subtracted from the ECG segment to remove the DC component.

[0027] In step 208 of the residual ECG noise level estimation procedure 200 shown in FIG. 2, an estimated magnitude of the noise level (i.e., estimated noise energy) is calculated, for example, by taking the root mean square (RMS) amplitude (RMS of alternating current (AC) voltage) of the ECG segment (with linear trend / low pass / DC energy removed) or the peak-to-peak (PP) amplitude of the ECG segment. When calculating the estimated noise energy, the estimated noise energy value (e.g., RMS or PP amplitude value) may be normalized by the duration of the segment (or energy window). According to other exemplary embodiments, any known estimation technique may be used to calculate the estimated noise level of the segment, such as, but not limited to, spectral density estimation techniques.

[0028] Once the estimated noise level of each of the multiple ECG segments of the ECG data has been calculated, then, at step 210 of the residual ECG noise level estimation procedure 200 shown in FIG. 2, a subset of the multiple ECG segments (e.g., one or more) is selected based on the ECG segment having the smallest estimated noise level (e.g., smallest RMS or PP amplitude), and an estimated average noise level of the ECG data is calculated by taking the average of the estimated noise levels of the selected subset of ECG segments. The noise estimate is preferably averaged over the multiple segments to provide a more reliable estimate. The average of the estimated noise levels of the selected subset of ECG segments may be a simple average or a weighted average. For example, the weighted average may take into account previous noise level estimates to determine the weights and / or may take into account the consistency of the noise estimate over time (e.g., if the noise estimate changes rapidly from one second of signal to the next second of signal, noise or error may be present in the estimate). According to an exemplary embodiment, a subset of the multiple segments (e.g., three segments) is used. In another exemplary embodiment, the noise estimate may be averaged over all segments of the original ECG data signal. In an alternative exemplary embodiment, only one estimated noise level (e.g., the minimum noise level) is used and no averaging is taken.

[0029] According to an exemplary embodiment of the present invention, the noise energy of the ECG segment having the minimum noise energy is preferably used to estimate the noise energy of the ECG data, however, according to alternative exemplary embodiments, other noise energy estimates other than the lowest value may be used, such as sampling the noise energy estimate at the lowest 10% percentile.

[0030] Optionally, in step 212 of the residual ECG noise level estimation procedure 200 shown in FIG. 2, the steps (e.g., steps 202-210) for calculating the estimated average noise level may be repeated for multiple ECG data (e.g., X ECG signals of 1 second duration each, or equivalently, a longer X second ECG signal divided into 1 second signals), and noise statistics such as the noise mean and standard deviation may be generated across the multiple ECG signals. According to an exemplary embodiment, ECG segments of electrical activity where noise should not be measured may be marked or flagged. For example, if the system knows that a special condition is occurring at a particular time, the system may temporarily ignore or stop the calculations of the noise level estimation procedure (e.g., during a particular signal period, such as during ablation, or during ventricular far-field detection during atrial mapping).

[0031] The estimated noise energy of the ECG data generated in step 210 may be provided to or used by a system or algorithm, or may be provided directly to a user for analysis or troubleshooting, in a variety of applications. Several examples of applications and uses of the estimated noise level of the ECG signal generated using the residual ECG noise level estimation procedure 200 shown in FIG. 2 are described below.

[0032] According to an exemplary embodiment of the present invention, the electrocardiogram system may be combined with other medical systems, such as a real-time 3D cardiac imaging system for visualizing cardiac activity and defects, and / or a cardiac ablation system for correcting cardiac rhythm abnormalities known as arrhythmias by creating lesions to destroy tissue in the heart that contributes to the rhythm abnormality. One example of a real-time 3D imaging system for cardiac ablation is the CARTO® 3 System, produced by Biosense Webster®, Inc., a subsidiary of Johnson & Johnson. The CARTO® 3 System uses electromagnetic technology to create a 3D map of the patient's cardiac structure, show the exact location and orientation of the catheter in the heart, and provide an ECG of the electrical signals in the heart at each location. In some applications, different catheters may be used with the CARTO® 3 System, and the residual ECG noise level estimation procedure 200 shown in FIG. 2 may be used to compare noise performance between different catheter CARTO® 3 Systems. The following example compares several points collected with different catheters at the same site in the ventricle and under similar arrhythmia conditions. The signals were extracted to visualize the ECG signals in raw form (without filtering), raw form after power filtering (but without high-pass and / or low-pass filtering), and processed form (with power, high-pass and low-pass filtering). Further examples of filters that may be used (in addition to the power filter) to process the ECG signal prior to ECG noise energy estimation include, but are not limited to, a linear regression median filter, a differential filter, and / or a high-pass filter (e.g., to remove baseline drift prior to ECG noise energy estimation).

[0033] 3A and 3B show examples of different levels of ECG signals generated using a first type of catheter and a second type of catheter, respectively, in a CARTO system.

[0034] FIG. 3A shows an exemplary distal unipolar ECG signal taken from a low voltage point (0.2 mV) obtained from a posteroinferior view of the right atrium (RA) ventricle using a first type of catheter, and FIG. 3B shows an exemplary distal unipolar ECG signal taken from a low voltage point (0.2 mV) obtained from a posteroinferior view of the RA ventricle using a second type of catheter. Both FIG. 3A and 3B show the ECG signal in raw form (without filtering), raw form after power filtering, and processed form (CARTO signal with power filtering, high pass filtering, and low pass filtering). The residual ECG noise level estimation procedure 200 described in FIG. 2 can be applied to either of the signals in FIG. 3A and 3B to compare the noise performance of the two different types of catheters. In the examples of FIG. 3A and 3B, it can be observed that the ECG noise levels in the CARTO system in the processed (CARTO) signals using either catheter appear to be nearly identical (i.e., the difference in the signal pattern of FIG. 3A compared to FIG. 3B is minimal). Therefore, no meaningful analysis of the noise level can be assessed based on the processed CARTO signals. However, the ECG noise levels observed in the raw ECG signals are different between the two catheters.

[0035] FIG. 3C shows an exemplary 1 second (unipolar) ECG signal in raw format generated using a first type catheter of the CARTO system, and shows one exemplary segment used to calculate a residual ECG noise level estimate according to the procedure shown in FIG. 2. Similarly, FIG. 3D shows an exemplary 1 second (unipolar) ECG signal in raw format generated using a second type catheter of the CARTO system, and shows one exemplary segment used to calculate a residual ECG noise level estimate according to the procedure shown in FIG. 2. In both FIG. 3C and FIG. 3D, a quieter segment with less trend / DC / low pass energy is shown, and is approximately 50 ms in duration. According to the residual ECG noise level estimation procedure 200 shown in FIG. 2, any short duration segment can be used by applying the techniques described herein to remove any trend / DC / low pass energy and isolate the noise energy.

[0036] In an exemplary application of the residual ECG noise level estimation procedure 200 shown in Figure 2 to a segment of the raw ECG signal in Figures 3C and 3D (which may be averaged over a number of one-second ECG signals, e.g., 300 one-second ECG signals), it can be determined that the noise level in the raw ECG signal generated by the first type of catheter (Figure 3C) is on the order of 57 μV, which is more than twice as large as the noise level of about 21 μV in the raw ECG signal generated by the second type of catheter (Figure 3D). Spectral analysis comparing the two raw signals also supports this finding, indicating that the higher noise level is due to power harmonics.

[0037] Thus, a comparison of the ECG signals of the different catheters based on the residual ECG noise level estimates shows that the raw signal shown in Figure 3A is noisier than the raw signal in Figure 3B, while the processed signals appear to be equivalent. This type of analysis is useful in process production control, for example, to determine that a first type of catheter has inferior noise performance to a second type of catheter, and to determine which type of catheter should be used in different applications. As explained above, the analysis based on the ECG noise level estimates can be performed on various levels of the signal, including in raw form, after power filtering, or after any user-selectable filtering.

[0038] According to an exemplary embodiment, the residual ECG noise level estimation procedure of the present invention may be used to estimate noise energy levels in systems with one or more intracardiac unipolar ECG signals that are sensitive to noise of various frequencies, as well as in algorithms designed to analyze unipolar ECG signals. According to one exemplary embodiment, noise levels may be estimated for each catheter (if more than one catheter is used) and the catheters may be compared with respect to their corresponding estimated noise levels. According to another exemplary embodiment, noise levels may be estimated and compared for different levels of ECG output (e.g., in raw form, in power filtered form, or after a user-selectable filter).

[0039] According to another exemplary embodiment, the estimated noise level of the ECG signal generated using the residual ECG noise level estimation procedure 200 shown in Figure 2 may be used to dynamically modify certain algorithms. For example, mapping algorithms for signals detected in the presence of noise (e.g., wavefront and finder algorithms) may use the real-time estimated noise level to dynamically change the detection threshold of the mapping signal, thus allowing detection of low (amplitude) signals when the noise level is low and increasing the detection threshold of the signal when the noise is high.

[0040] According to another exemplary embodiment, the estimated noise level of the ECG signal generated using the residual ECG noise level estimation procedure 200 shown in FIG. 2 can be used to compare instantaneous noise level estimates to a history of noise level estimates collected for a given system (e.g., a CARTO system). For example, a comparison of estimated noise levels over time can be used to monitor the performance of a power filter algorithm and provide a warning to a system or user when a power filter malfunctions. More generally, a comparison of estimated noise levels over time can be used to alert a system or user to an identified problem and aid in troubleshooting (e.g., comparing noise levels using different cables to identify a faulty cable).

[0041] According to another exemplary embodiment, the estimated noise level of an ECG signal generated using the residual ECG noise level estimation procedure 200 shown in Figure 2 may be used to test a device (e.g., a catheter) during its manufacture to ensure proper design and connectivity. According to another exemplary embodiment, the estimated noise level of an ECG signal generated using the residual ECG noise level estimation procedure 200 shown in Figure 2 may be used to collect big data from a fleet of systems to determine which components, systems, and / or conditions generate noise and / or to verify that system changes, including software upgrades, do not result in performance degradation.

[0042] Many variations are possible based on the disclosure herein: Although features and elements have been described above in specific combinations, each feature or element may be used alone without the other features and elements, or in various combinations with other features and elements, with or without the other features and elements.

[0043] The systems and procedures described herein may be implemented in hardware and / or software. A computer-based system for performing electrocardiography may be capable of executing software modules that introduce additional functionality, including the procedures described herein. The procedures described herein may enable advanced cardiac visualization and diagnostic capabilities to enhance a physician's ability to diagnose and treat cardiac rhythm disorders. Although the procedures disclosed herein are described with respect to an electrocardiography procedure in the heart, the devices and procedures may be used for electrophysiological procedures in other parts of the body as well. Examples include, but are not limited to, electroencephalography in the brain, electrooculography in the eye, and electropneumotography in the lungs. Additionally, the procedures disclosed herein may be used to estimate noise energy in any electrical signal, including non-biomedical electrical signals.

[0044] The provided methods may include implementation in a general purpose computer, processor, or processor core. Suitable processors include, by way of example, a general purpose processor, a special purpose processor, a conventional processor, a digital signal processor (DSP), multiple microprocessors, one or more microprocessors associated with a DSP core, a controller, a microcontroller, an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) circuit, any other type of integrated circuit (IC), and / or a state machine. Such a processor may be manufactured by configuring a manufacturing process using the results of processed hardware description language (HDL) instructions and other intermediate data such as a netlist (such instructions may be stored in a computer readable medium). The result of such processing may be a mask work, which is then used in a semiconductor manufacturing process to manufacture a processor that performs the methods described herein.

[0045] The methods or flow charts provided herein can be implemented in a computer program, software, or firmware embodied in a non-transitory computer-readable storage medium and executed by a general-purpose computer or processor. Examples of non-transitory computer-readable storage media include ROM, random access memory (RAM), registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, and optical media such as CD-ROM disks and digital versatile disks (DVDs).

[0046] [Embodiment] (1) A system for estimating residual noise energy in an electrocardiogram (ECG) signal, the system comprising: a plurality of electrodes positioned proximate to a cardiac structure and configured to measure electrical signals of the cardiac structure to generate the ECG signal; 1. A processor comprising: Segmenting the ECG signal into a plurality of segments; For each of the plurality of segments, removing linear trend energy and direct current (DC) energy from the segment and calculating an estimated noise energy for the segment; selecting a subset of the plurality of segments having a minimum estimated noise energy; and estimating the residual noise energy of the ECG signal by calculating an average of the estimated noise energy over a subset of the segments. (2) The system of embodiment 1, wherein the plurality of electrodes includes at least one of an intracardiac electrode mounted on a catheter configured to be inserted into a chamber of the cardiac structure and a surface electrode located on a body surface external to the cardiac structure. (3) The system of embodiment 1, wherein adjacent segments in the plurality of segments overlap partially in time. (4) The system of embodiment 1, wherein the ECG signal is an unprocessed unipolar or bipolar ECG signal before any filtering. (5) The system described in embodiment 1, further comprising at least one power filter configured to filter the ECG signal.

[0047] (6) The system of embodiment 1, further comprising at least one of a linear regression median filter, a differential filter, or a high-pass filter for filtering the ECG signal. (7) The system of embodiment 1, wherein the processor is further configured to select a duration of the segment such that the trend energy is minimized. (8) The system of embodiment 1, wherein the processor is configured to calculate the estimated noise energy of the segment by taking the root mean square (RMS) amplitude or peak-to-peak (PP) amplitude of the segment. (9) The system of embodiment 1, wherein the processor is further configured to normalize the estimated noise energy of the segment by the duration of the segment. (10) The plurality of electrodes is further configured to generate a plurality of ECG signals; 2. The system of claim 1, wherein the processor is configured to estimate the residual noise energy of each of the plurality of ECG signals and generate noise statistics for the entirety of the plurality of ECG signals.

[0048] (11) A method for estimating residual noise energy in an electrocardiogram (ECG) signal, the method comprising: measuring electrical signals of the cardiac structure using a plurality of electrodes positioned proximate the cardiac structure to generate the ECG signal; Segmenting the ECG signal into a plurality of segments; For each of the plurality of segments, removing linear trend energy and direct current (DC) energy from the segment and calculating an estimated noise energy for the segment; selecting a subset of the plurality of segments having a minimum estimated noise energy; and estimating the residual noise energy of the ECG signal by averaging the estimated noise energy over the subset of segments. (12) The method of embodiment 11, wherein the plurality of electrodes includes at least one of an intracardiac electrode mounted on a catheter configured to be inserted into a chamber of the cardiac structure and a surface electrode located on a body surface external to the cardiac structure. (13) The method of embodiment 11, wherein adjacent segments in the plurality of segments overlap partially in time. (14) The method of embodiment 11, wherein the ECG signal is an unprocessed unipolar or bipolar ECG signal before any filtering. (15) The method of embodiment 11, further comprising using a power filter to filter the ECG signal.

[0049] (16) The method of embodiment 11, further comprising using at least one of a linear regression median filter, a differential filter, or a high-pass filter to filter the ECG signal. (17) The method of embodiment 11, further comprising selecting a duration of the segment such that the trend energy is minimized. (18) The method of embodiment 11, wherein the estimated noise energy of the segment is calculated by taking the root mean square (RMS) amplitude or peak-to-peak (PP) amplitude of the segment. (19) The method of embodiment 11, further comprising normalizing the estimated noise energy of the segment by the duration of the segment. (20) generating a plurality of ECG signals; estimating the residual noise energy of each of the plurality of ECG signals; 12. The method of claim 11, further comprising generating noise statistics for the plurality of ECG signals.

Claims

1. 1. A system for estimating residual noise energy in an electrocardiogram (ECG) signal, the system comprising: a plurality of electrodes positioned proximate to a cardiac structure and configured to measure electrical signals of the cardiac structure to generate the ECG signal; 1. A processor comprising: Segmenting the ECG signal into a plurality of segments; For each of the plurality of segments, removing linear trend energy and direct current (DC) energy from the segment and calculating an estimated noise energy for the segment; selecting a subset of the plurality of segments having a minimum estimated noise energy; and estimating the residual noise energy of the ECG signal by calculating an average of the estimated noise energy over the subset of the segments.

2. 2. The system of claim 1, wherein the plurality of electrodes includes at least one of an intracardiac electrode mounted on a catheter configured to be inserted into a chamber of the cardiac structure and a surface electrode located on a body surface external to the cardiac structure.

3. The system of claim 1 , wherein adjacent segments in the plurality of segments overlap in time.

4. The system of claim 1 , wherein the ECG signal is an unprocessed unipolar or bipolar ECG signal before any filtering.

5. The system of claim 1 , further comprising at least one power filter configured to filter the ECG signal.

6. The system of claim 1 , further comprising at least one of a linear regression median filter, a differential filter, or a high pass filter for filtering the ECG signal.

7. The system of claim 1 , wherein the processor is further configured to select a duration of the segment such that the trend energy is minimized.

8. The system of claim 1 , wherein the processor is configured to calculate the estimated noise energy of the segment by taking a root-mean-square (RMS) amplitude or a peak-to-peak (PP) amplitude of the segment.

9. The system of claim 1 , wherein the processor is further configured to normalize the estimated noise energy of the segment by a duration of the segment.

10. the plurality of electrodes are further configured to generate a plurality of ECG signals; The system of claim 1 , wherein the processor is configured to estimate the residual noise energy for each of the plurality of ECG signals and generate noise statistics for the entire plurality of ECG signals.

11. A method of operating a system for estimating residual noise energy in an electrocardiogram (ECG) signal, the system comprising: a plurality of electrodes positioned proximate to a cardiac structure and configured to measure electrical signals of the cardiac structure to generate an ECG signal; and a processor, the method comprising: The processor segments the ECG signal into a plurality of segments; The processor, for each of the plurality of segments, removes linear trend energy and direct current (DC) energy from the segment and calculates an estimated noise energy for the segment; the processor selecting a subset of the plurality of segments having a minimum estimated noise energy; and the processor estimating the residual noise energy of the ECG signal by calculating an average of the estimated noise energy over the subset of segments.

12. 12. The method of claim 11, wherein the plurality of electrodes includes at least one of intracardiac electrodes mounted on a catheter configured to be inserted into a chamber of the cardiac structure and surface electrodes located on a body surface external to the cardiac structure.

13. The method of claim 11 , wherein adjacent segments in the plurality of segments overlap in time.

14. The method of claim 11 , wherein the ECG signal is an unprocessed unipolar or bipolar ECG signal before any filtering.

15. The method of claim 11, wherein the system further comprises at least one power filter configured to filter the ECG signal.

16. The method of claim 11, wherein the system further comprises at least one of a linear regression median filter, a differential filter, or a high pass filter for filtering the ECG signal.

17. The method of claim 11, further comprising the processor selecting a duration of the segment such that the trend energy is minimized.

18. The method of claim 11, wherein the processor calculates the estimated noise energy of the segment by taking the root mean square (RMS) amplitude or peak-to-peak (PP) amplitude of the segment.

19. The method of claim 11, further comprising the processor normalizing the estimated noise energy of the segment by the duration of the segment.

20. The plurality of electrodes are further configured to generate a plurality of ECG signals; the processor estimating the residual noise energy of each of the plurality of ECG signals; The method of claim 11 , further comprising the processor generating noise statistics for the plurality of ECG signals.

Images