Patent Publication Number: US-2021186348-A1

Title: Solving double potential problems

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to invasive medical procedures, and specifically to analyzing results of a cardiac invasive procedure. 
     BACKGROUND OF THE INVENTION 
     An invasive cardiac procedure typically includes acquiring intra-cardiac (IC) electrocardiograph (ECG) signals, and analyzing the signals. Analysis of IC ECG signals is well known in the art. 
     For example, U.S. Pat. No. 10,314,542 to Bar-Tal et al. describes a system for determining regions of interest for heart ablation using fractionation. The method can comprise detecting, via sensors, electro-cardiogram (ECG) signals, each ECG signal detected via one of the sensors and indicating electrical activity of a heart. The system also includes determining regions of interest for heart ablation in accordance with the fractionation. 
     U.S. Patent Application No. 2018/0235495 to Rubenstein describes cardiac mapping catheters and methods for using the catheters. A catheter can detect the presence, direction and/or source of a depolarization wave front associated with cardiac arrhythmia. 
     U.S. Pat. No. 10,335,052 to El Haddad describes a device for analyzing electrophysiological data. The device generates a signal indicative for a presence of a pulmonary vein potential component using processing means adapted for performing a stepwise analysis of the electrophysiological data. 
     U.S. Pat. No. 6,236,883 to Ciaccio et al. describes a method comprising the steps of identifying and localizing reentrant circuits from electrogram features using feature detection and localization (FDL) algorithms. 
     U.S. Patent Application No. 2017/0079539 to Chauhan et al. describes a system for identifying focal source locations of electrophysiological activity in an organ. The system may also be used to guide catheter ablation of the organ. 
     SUMMARY OF THE INVENTION 
     An exemplary embodiment of the present invention provides a method for electrophysiological assessment, including: 
     acquiring electrical signals from myocardial tissue at multiple locations in a vicinity of a region of ablated tissue in a chamber of a heart; 
     deriving from the electrical signals respective annotations, which are indicative of times within a cycle of the heart at which a conduction wave in the myocardial tissue traversed the locations; 
     identifying a first location, at a first distance from the region of the ablated tissue, where the electrical signals include a double-potential signal, having a first annotation and a second annotation at different, respective times within the cycle of the heart; 
     identifying, in proximity to the first location, a second location, at a second distance from the region of the ablated tissue, greater than the first distance, where the electrical signals have a third annotation; 
     selecting one of the first annotation and the second annotation that is closest to the third annotation as a valid annotation for the first location; and 
     displaying the valid annotation on an electroanatomical map of the heart. 
     In a disclosed exemplary embodiment the electrical signals at the second location include a single-potential signal or a double-potential signal. 
     In another disclosed exemplary embodiment the chamber includes an atrium of the heart. 
     In yet another disclosed exemplary embodiment the chamber includes a ventricle of the heart. 
     In a further disclosed exemplary embodiment the region of the ablated tissue includes one or more separated points. Alternatively or additionally the region of the ablated tissue includes a line segment. 
     In an alternative exemplary embodiment displaying the valid annotation on the electroanatomical map includes deriving a local activation time (LAT) for the first location from the valid annotation, and incorporating the LAT into the map. 
     In a further alternative exemplary embodiment the first location is within a preset threshold distance from the region of ablated tissue. The preset threshold distance may be 10 mm. 
     There is further provided, according to an exemplary embodiment of the present invention, apparatus for electrophysiological assessment, including: a display, configured to present an electroanatomical map of a heart; 
     a probe, configured to acquire electrical signals from myocardial tissue at multiple locations in a vicinity of a region of ablated tissue in a chamber of the heart; and 
     a processor, configured to: 
     derive from the electrical signals respective annotations, which are indicative of times within a cycle of the heart at which a conduction wave in the myocardial tissue traversed the locations, 
     identify a first location, at a first distance from the region of the ablated tissue, where the electrical signals include a double-potential signal, having a first annotation and a second annotation at different, respective times within the cycle of the heart, identify, in proximity to the first location, a second location, at a second distance from the region of the ablated tissue, greater than the first distance, where the electrical signals have a third annotation, 
     select one of the first annotation and the second annotation that is closest to the third annotation as a valid annotation for the first location, and 
     display the valid annotation on the electroanatomical map of the heart. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will be more fully understood from the following detailed description of the exemplary embodiments thereof, taken together with the drawings, in which: 
         FIG. 1  is a schematic illustration of a double potential analysis system, according to an exemplary embodiment of the present invention; 
         FIG. 2  is a schematic illustration of a distal end of a catheter used in the system, according to an exemplary embodiment of the present invention; 
         FIG. 3  shows examples of intra-cardiac electrocardiograph signals, according to an exemplary embodiment of the present invention; 
         FIG. 4A  is a schematic illustration of an electroanatomical map of a section of heart chamber tissue, according to an exemplary embodiment of the present invention; 
         FIG. 4B  is a schematic illustration of a map of a section of heart chamber tissue, after ablation has been performed, according to an exemplary embodiment of the present invention; and 
         FIG. 5  is a flowchart of steps of an algorithm performed by a processor of the system, according to an exemplary embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     Overview 
     If a section of heart tissue has been ablated, typically along an ablation line, there is a high probability of the occurrence of double potentials in locations near the ablation, i.e., instead of there being a signal with one annotation, the signal has two annotations. Only one of the annotations is representative of the time at which a conduction wave traverses a given location but a system processor may choose the wrong one. 
     In exemplary embodiments of the present invention the system processor is aware of the location of ablation regions. For points close to an ablation region, and where double potentials occur, the processor uses this awareness to choose which of the double potential annotations is assumed to be the correct one. The chosen annotation is the one closer in time to the annotations of neighboring points that are farther from the ablation region. 
     Thus, in an exemplary embodiment of the present invention electrical signals are acquired from myocardial tissue at multiple locations in a vicinity of a region of ablated tissue in a chamber of a heart. From the electrical signals respective annotations, which are indicative of times within a cycle of the heart at which a conduction wave in the myocardial tissue traversed the locations, are derived. 
     A first location that is at a first distance from the region of the ablated tissue is identified, the first location being where the electrical signals comprise a double-potential signal, having a first annotation and a second annotation at different, respective times within the cycle of the heart. 
     A second location, that is in proximity to the first location, and that is at a second distance, greater than the first distance, from the region of the ablated tissue, is identified. The second location has electrical signals that have a third annotation. 
     The one of the first annotation and the second annotation that is closest to the third annotation is selected as a valid annotation for the first location. The valid annotation is then displayed on an electroanatomical map of the heart. 
     System Description 
     In the following description, like elements in the drawings are identified by like numerals, and like elements are differentiated as necessary by appending a letter to the identifying numeral. 
     Reference is now made to  FIG. 1 , which is a schematic illustration of a double potential analysis system  20 , and to  FIG. 2 , which is a schematic illustration of a distal end of a catheter used in the system, according to an embodiment of the present invention. For simplicity and clarity, the following description, except where otherwise stated, assumes a medical procedure is performed by an operator  22  of system  20 , herein assumed to be a medical practitioner, wherein the operator inserts a catheter  24  into a left or right femoral vein of a patient  28 . The procedure is assumed to comprise investigation of a chamber of a heart  34  of the patient, and in the procedure, the catheter is initially inserted into the patient until a distal end  32  of the catheter, also herein termed probe  32 , reaches the heart chamber. The chamber typically comprises an atrium or a ventricle of the heart. 
     System  20  may be controlled by a system processor  40 , comprising a processing unit (PU)  42  communicating with an electromagnetic tracking module  36  and/or a current tracking module  37 . PU  42  also communicates with an ablation module  39  and an ECG (electrocardiograph) module  43 . The functions of the modules are described in more detail below. PU  42  also communicates with a memory  44 . Processor  40  is typically mounted in a console  46 , which comprises operating controls  38 , typically including a pointing device such as a mouse or trackball, that operator  22  uses to interact with the processor. The processor uses software stored in memory  44  to operate system  20 . Results of the operations performed by processor  40  are presented to the operator on a display  48 . The results, which are typically in the form of an electroanatomical map  49  of heart  34 , enable the operator to form an electrophysiological assessment of the heart. The software may be downloaded to processor  40  in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory. 
     For tracking the path of probe  32  in a mapping region containing heart  34 , exemplary embodiments of the present invention use at least one of a current based tracking system  21  and an electromagnetic based tracking system  23 . Both systems are described below. 
     Tracking system  21  comprises a current measuring tracking system, similar to that described in U.S. Pat. No. 8,456,182 to Bar-Tal et al., whose disclosure is incorporated herein by reference. The Carto® system produced by Biosense-Webster of 33 Technology Drive, Irvine, Calif. 92618 USA, also uses a current measuring tracking system. The current measuring tracking system is under control of current tracking module  37 . Probe  32  has one or more probe electrodes  50 , herein by way of example assumed to comprise an electrode  50 A and an electrode  50 B, and in tracking system  21  module  37  injects currents to the one or more electrodes  50  being tracked. The currents are received, by a plurality of generally similar patch electrodes  77 , also herein termed patches, which are positioned on the skin of patient  28 , and transferred back to the module. 
     While conductive cabling to patch electrodes  77  and for other skin electrodes described herein is present for each of the electrodes, for clarity cabling is only shown in the figure for some of the electrodes. The currents between a given probe electrode  50  and skin patches  77  vary according to the location of the electrode, because, inter alia, of the different distances of the electrode from the patches, which cause different impedances between the given probe electrode and the different patches. Module  37  measures the different currents received by the different patches  77  on respective channels connected to the patches, and may be configured to generate an indication of the location of the given probe electrode from the different currents. 
     Electromagnetic tracking system  23  is similar to that described in U.S. Pat. No. 6,690,963 to Ben-Haim et al., whose disclosure is incorporated herein by reference, and to that used in the Carto™ system produced by Biosense-Webster. The electromagnetic tracking system is under control of electromagnetic tracking module  36 . The electromagnetic tracking system comprises a plurality of magnetic field generators, herein assumed to comprise three sets of generators  66 , each set comprising three orthogonal coils, so that the plurality of generators comprises a total of nine coils. Generators  66  are placed in known locations beneath patient  28 , the known locations defining a frame of reference of the generators. Module  36  controls, inter alia, the amplitude and frequency of the alternating magnetic fields produced by the generators. 
     The alternating magnetic fields interact with a coil  51  located in probe  32 , so as to generate alternating electropotentials in the coil, and the electropotentials are received as a signal by tracking module  36 . The module, together with processing unit  42 , analyzes the received signal, and from the analysis is able to determine a position, i.e., a location and an orientation, of the probe coil in the defined frame of reference. 
     Typically the tracking by either or both of the systems may be presented visually on display  48 , for example by incorporating an icon representing the probe into map  49  of heart  34 , as well as a path taken by the icon. For clarity, in the following description, only electromagnetic tracking system  23  is assumed to be use, but the description may be adapted, mutatis mutandis, for cases where both system  23  and system  21  are used, or if only system  21  is used. 
     Ablation module  39  comprises a radiofrequency (RF) generator which delivers RF power to a region of heart  34  that is selected by operator  22 , so as to ablate the region. Operator  22  selects the region by positioning an ablation probe, with an ablation electrode, at the region. In some embodiments probe  32  and one of electrodes  50 , such as electrode  50 B, may be used as an ablation probe and an ablation electrode. Alternatively a separate ablation probe and ablation electrode may be used for the ablation provided by module  39 . 
     ECG module  43  receives intra-cardiac (IC) ECG signals acquired by electrodes  50  when the electrodes are in contact with myocardial tissue of a chamber of heart  34 . The ECG module together with PU  42  analyzes the signals, as described below, to find, inter alia, local activation times (LATs) of the signals. The module typically formulates its measurements relative to a reference ECG signal, such as may be provided by an electrode positioned in the coronary sinus of heart  34 . 
       FIG. 3  shows examples of IC ECG signals, according to an embodiment of the present invention. Signals  100  and  102  are acquired by electrodes  50  in contact with respective locations of the myocardial tissue of the heart chamber, herein by way of example assumed to be an atrium. The signals are voltage versus time signals, and for simplicity axes for the signals are not illustrated in  FIG. 3 . PU  42  and module  43  analyze each signal to determine one or more annotations of each of the signals. An annotation for a given location is indicative of a time, the LAT, in the cycle of the beating heart at which a conduction wave in the heart traverses the location, and is assumed herein to comprise an ordered pair of the signal, i.e., a voltage V and a time t of the signal. 
     As is known in the art, the annotation for a given ECG signal may be set by different methods. For example, the annotation for a ventricle may be selected to be at a point on the QRS complex wherein the negative slope is steepest, i.e., wherein 
     
       
         
           
             
               d 
                
               V 
             
             
               d 
                
               t 
             
           
         
       
     
     is most negative. For an atrium the annotation may be set at the maximum of the P-wave of the signal, or alternatively at the time where 
     
       
         
           
             
               d 
                
               V 
             
             
               d 
                
               t 
             
           
         
       
     
     of the P-wave is most negative. 
     In the following description, except where otherwise stated, IC ECG signals are assumed to be acquired from an atrium of the heart, and the annotation for the acquired signals is assumed to be at the time of the maximum of the P-wave signal. Cases where the annotation of the P-wave is at other positions, such as at the time where 
     
       
         
           
             
               d 
                
               V 
             
             
               d 
                
               t 
             
           
         
       
     
     is most negative, are noted further below. 
     Signal  100  illustrates a signal having a single annotation  110 , at the peak of the P-wave, and such signals are also termed single potential signals. Signals having a single annotation, such as signal  100 , are typically generated by heart  34  when it is beating in sinus rhythm. 
     Signal  102  illustrates a signal having two annotations  114 ,  118 , wherein the P-wave has two peaks, and such signals are termed double-potential signals. While a heart beating in sinus rhythm may generate double-potential signals, the presence of double potentials may be indicative of, for example, an arrhythmia, scar tissue, or ablated tissue. 
     As explained below, signals such as those illustrated in  FIG. 3  are used to produce electroanatomical map  49  of heart  34 . 
       FIG. 4A  is a schematic illustration of an electroanatomical map  150  of a section of an atrium of heart  34 , according to an embodiment of the present invention. Map  150  is produced before ablation of myocardial tissue of heart  34  and the map illustrates a portion of electroanatomical map  49 . 
     To produce map  49 , a three-dimensional (3D) map of the heart chamber may be first generated, by moving distal end  32  within the heart chamber, and tracking and recording positions of the distal end using one of the tracking systems referred to above. The recorded positions comprise a point cloud of positions within and at a surface of the heart chamber, and processor  40  may then analyze the point cloud, by methods which are well known in the art, to produce a 3D envelope enclosing the point cloud, the envelope corresponding to the tissue surface of the atrium. 
     Once the 3D map has been produced, the surface of the atrium may be characterized by acquiring and recording IC ECG signals from locations on the surface of the atrium. The signal acquisition may be performed using electrodes  50  of distal end  32 , while recording the location of the distal end, and thus of the electrodes. The characterization may be as illustrated above for the signals of  FIG. 3 , comprising processor  40  calculating annotations for the signals. From the annotations the processor may initially assign LATs to the locations where the IC ECG signals are acquired, by methods which are well known in the art. 
     For single potential signals the LAT typically corresponds to the time of the single potential annotation, i.e., the time of the P-wave maximum. Thus, for signal  100 , the LAT is at the time of annotation  110 . For double potential signals the LAT, except as described further below, is assumed to correspond to the time of the annotation having the largest voltage. (If the annotation is defined in terms of the 
     
       
         
           
             
               d 
                
               V 
             
             
               d 
                
               t 
             
           
         
       
     
     of the signal, the LAT may be assumed to correspond to the time of the annotation having the most negative 
     
       
         
           
             
               
                 
                   d 
                    
                   V 
                 
                 
                   d 
                    
                   t 
                 
               
               . 
             
             } 
           
         
       
     
     Thus, for signal  102 , if annotation  114  has a larger voltage than annotation  118 , the LAT is at the time of annotation  114 . In displays of the annotated signals, referred to further below, typically only the annotation selected for the LAT is superimposed on signals. In  FIG. 3  annotation  114  has been drawn as a filled circle to indicate it is the annotation that has been selected for the LAT of signal  102 . Similarly, annotation  110  has been drawn as a filled circle to indicate it is the annotation that has been selected for the LAT of signal  100 . 
     Once the LAT values for specific locations have been determined, the processor may overlay the measured values on the 3D map of the chamber, typically interpolating between the values, to produce an electroanatomical map. The different LAT values are typically illustrated in maps  150  and  49  as different colors, but are shown schematically for regions  152 ,  154 ,  156  of the atrium in  FIG. 4A  as respective different types of shading  152 L,  154 L,  156 L. The values, typically in ms, of the LATs may be shown on display  48  as a legend for the map, as is schematically illustrated in  FIG. 4A . 
     Operator  22  may assess map  150 , and from the assessment may decide to ablate a region of the myocardial tissue, typically to correct a problem such as arrhythmia that is occurring in heart  34 . To perform the ablation, the operator moves distal end  32  so that electrodes  50  are at a selected location of the tissue. The movement is tracked by one of the tracking systems referred to above, and the selected location, when reached, may be recorded by processor  40 . 
     In addition to recording the selected location, once the operator has performed ablation at the location, the location may be marked on map  49 , as described below with reference to  FIG. 4B . 
       FIG. 4B  is a schematic illustration of a map  160  of a section of the atrium of heart  34 , after ablation has been performed, according to an embodiment of the present invention. Except as described below, map  160  is substantially similar to map  150 , so that the positions of regions  152 ,  154 , and  156  are the same in the two maps. Map  160  also comprises a marked location  164  on the atrium indicating where ablation has been performed. By way of example, the ablation is assumed to have been on a line, but it will be appreciated that substantially any type of figure, including point regions, may be marked on the map of the atrium in a similar manner to location  164 . 
     After the ablation illustrated in map  160 , operator  22  may re-acquire IC ECG signals from the tissue, to assess the efficacy of the ablation and to update the map. The flowchart of  FIG. 5 , below, illustrates steps of an algorithm performed by processor  40  when the operator re-acquires the signals. 
       FIG. 5  is a flowchart of steps of an algorithm performed by processor  40 , according to an embodiment of the present invention. In an initial step  180  operator  22  assesses an electroanatomical map of an atrium of heart  34 , herein assumed to correspond to map  49 , and as a result of the assessment the operator decides to ablate a region of the myocardial tissue of the atrium. The ablated region may comprise one or more separated points of the tissue; alternatively, the ablated region may be in the form of a line segment, similar to that illustrated in map  160  of  FIG. 4B . 
     In a record step  184 , processor  40  records the locations of the ablation performed, and also illustrates the locations on map  49  displayed to the operator. The illustration typically comprises incorporating one or more icons into map  49 . 
     In a signal acquisition step  188 , the operator moves probe  32  to locations on the surface of the atrium, and electrode  50  acquires respective ECG signals at each of the locations. Processor  40 , together with module  43 , stores the signals. For each acquired ECG signal the processor analyzes the signal to determine one or more annotations in the signal. The processor stores the annotations and the locations at which the signals providing the annotations were acquired. 
     Except where stated otherwise, processor  40  iterates the following steps of the flowchart, as is shown by arrows  186 , in order to analyze the acquired results. The iterated steps of the flowchart are shown in  FIG. 5  as enclosed in a dashed line rectangle  190 . In the iteration, the processor separately analyzes each of the acquired ECG signals, and their stored annotations and locations as described above. 
     In a first decision step  192 , processor  40  checks if the signal is a single potential signal, i.e., if the signal has a single annotation. If decision  192  returns positive, in an assignation step  194  the processor assigns the time of the annotation to be the LAT of the location. If decision  192  returns negative, the flowchart continues to a double potential step  196 . 
     In step  196  processor  40  determines that the analyzed signal is a double potential signal. 
     In a second decision step  200 , processor  40  calculates the respective distances of the location of the signal from the ablated regions, and assesses if the location is close to the regions. I.e., the processor calculates the distances of the location of the signal from all of the ablated regions, and determines if any of the distances are within a preset threshold distance. In one embodiment the threshold distance is set to be 10 mm. 
     If step  200  returns negative, i.e., the signal location is not within the preset threshold distance, so is far from the ablated regions, in a further assessment step  202  the processor assumes the LAT for the location of the double potential corresponds to the annotation with the largest potential. 
     If step  200  returns positive, i.e., the signal location is within the preset threshold distance, then the location is close to at least one of the ablated regions. In this case, in an annotation allocation step  204  the processor assumes that the LAT for the location, the valid annotation, is the annotation that is closest to an annotation for a neighboring location that is farther from the ablated region. It will be understood that the signal of the neighboring location may be a single potential signal or a double potential signal. 
     Once processor  40  has completed analysis of all the ECG signals acquired in step  188 , i.e., the processor has completed the iterative steps described above, the processor updates map  49  in an update step  208 . In the update step the processor incorporates the valid annotations of steps  194 ,  202 , and  204  into map  49 , by displaying LAT values of the annotations in the map. By inspection of the updated map, operator  22  is able to use results generated as described above to assess the efficacy of the ablation performed in initial step  180 . 
     The description above assumes that the annotation of the P-wave is at the time of the maximum of the P-wave. The description may be changed, mutatis mutandis, to accommodate cases where the annotation of the P-wave is at other positions known in the art, such as at the time of the most negative 
     
       
         
           
             
               d 
                
               V 
             
             
               d 
                
               t 
             
           
         
       
     
     of the P-wave. 
     For clarity, the description above assumes that double-potential signals are acquired from an atrium of a heart, and are analyzed according to the algorithm of  FIG. 5 . The description above, mutatis mutandis, also applies to double-potential signals generated in a ventricle of the heart. Thus, embodiments of the present invention comprise analysis of double-potential signals generated in any chamber of the heart. 
     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.