Source: https://patents.google.com/patent/JP5819035B2/en
Timestamp: 2019-12-09 00:32:28
Document Index: 34204250

Matched Legal Cases: ['Application No. 60', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'Application No. 60', 'art\n2014']

JP5819035B2 - Computer program, computer readable medium and apparatus for generating complex fragmented atrial electrograms - Google Patents
Computer program, computer readable medium and apparatus for generating complex fragmented atrial electrograms Download PDF
JP5819035B2
JP5819035B2 JP2007003735A JP2007003735A JP5819035B2 JP 5819035 B2 JP5819035 B2 JP 5819035B2 JP 2007003735 A JP2007003735 A JP 2007003735A JP 2007003735 A JP2007003735 A JP 2007003735A JP 5819035 B2 JP5819035 B2 JP 5819035B2
JP2007003735A
JP2007185516A (en
JP2007185516A5 (en
アハロン・アボ
アハロン・ツルゲマン
クーンラウィー・ナデマニー
2006-01-12 Priority to US60/758,317 priority
2007-01-05 Priority to US11/620,370 priority
2007-01-11 Application filed by バイオセンス・ウエブスター・インコーポレーテツド filed Critical バイオセンス・ウエブスター・インコーポレーテツド
2007-07-26 Publication of JP2007185516A publication Critical patent/JP2007185516A/en
2010-01-28 Publication of JP2007185516A5 publication Critical patent/JP2007185516A5/ja
2013-05-29 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38109544&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP5819035(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
2015-11-18 Publication of JP5819035B2 publication Critical patent/JP5819035B2/en
This application is a US Provisional Patent Application No. 60 / 758,317, filed January 12, 2006, the disclosure of which is incorporated herein by reference (name: “Mapping of Complex Fractionated Atrial Electrogram) ”).
The present invention relates to the diagnosis and treatment of cardiac arrhythmias. In particular, the present invention relates to obtaining information indicative of local electrical activity in the ventricles and to identifying and treating proarrhythmic regions.
Cardiac arrhythmias such as atrial fibrillation are important causes of morbidity and mortality. Ben Heim (Ben), a method for detecting electrical characteristics of cardiac tissue, such as local activity time, as a function of exact location within the heart, is incorporated herein by reference in its entirety. U.S. Pat. Nos. 5,546,951, 6,690,963, and WO 96/05768, assigned to Haim) and assigned to the assignee of the present invention. Data is acquired by introducing one or more catheters with electrical and position sensors at the distal tip into the heart. A method for creating a map of cardiac electrical activity based on such data is given to Reisfeld, the disclosure of which is incorporated herein by reference, and assigned to the assignee of the present invention. Nos. 6,226,542 and 6,301,496. As described in these patent documents, position and electrical activity are usually initially measured at about 10 to about 20 points on the inner surface of the heart. These data points are usually sufficient to create a preliminary reconstruction or map of the heart surface. In order to create a more comprehensive map of the electrical activity of the heart, a preliminary map is often combined with data acquired at another point. In fact, in clinical settings, it is not uncommon to accumulate data at 100 or more sites to create a detailed and comprehensive map of ventricular electrical activity. The created detailed map can be used as a reference in determining a treatment procedure such as tissue ablation that changes the propagation of the electrical activity of the heart and restores normal heart rhythm.
A catheter that includes a position sensor can be used to determine the trajectory of points on the heart surface. Such trajectories can be used to infer motion characteristics such as contractility of cardiac tissue. A trajectory at a sufficient number of points in the heart as disclosed in US Pat. No. 5,738,096 to Ben Haim, the entire disclosure of which is incorporated herein by reference. If information is taken out as a sample, a map showing such movement characteristics can be created.
Electrical activity at a point in the heart is usually achieved by advancing a catheter with an electrical sensor at or near the distal tip to that point in the heart, bringing the electrical sensor into contact with the tissue, and collecting data at that point. Acquire and measure. One problem with creating a map of the ventricle using a catheter with only one distal tip electrode is to accumulate data point by point for the number of points required to create a detailed map of the entire ventricle. Therefore, a long time is required. Therefore, catheters with multiple electrodes have been developed to simultaneously measure electrical activity at multiple points in the ventricle.
During the past decade, several mapping studies in human atrial fibrillation have yielded the following important observations: There are three different patterns of atrial electrogram during sustained atrial fibrillation: only one potential, two potentials, and complex fractionated atrial electrogram (CFAE). The CFAE region represents the substrate sites of atrial fibrillation and is an important target site for ablation. Regions with persistent CFAE can be ablated to eliminate atrial fibrillation and even suppress triggering.
Nademanee et al., “A New Approach for Catheter Ablation of Atrial Fibrillation: Mapping of the Electrophysiologic Substrate”, Journal of The American College of Cardiology (J. Am. Coll. Cardiol.), 2004, 43 (11): 2044-2053, ablating the site showing complex fragmented atrial electrograms It has been proposed that it can be successfully treated. The author identified areas of CFAE during atrial fibrillation and performed radiofrequency ablation on those areas. As a result of ablation, atrial fibrillation was resolved in most cases.
In the Nademanee study described above, a map of CFAE was created manually. That is, the actual local electrogram was read during atrial fibrillation and the human operator identified the location of the CFAE by looking at the electrogram. The operator marked the CFAE site on the electrical activity map as a reference point for later ablation.
There is a need for an automatic process that can determine the position of a CFAE region and create a map thereof without the intervention of a skilled human operator. In response to this need, aspects of the present invention provide specialized system software and systems for an electroanatomical mapping system to automatically create a map of the region of CFAE within the ventricle. A method developed for this purpose analyzes the electrogram signal and counts the number of complexes that meet the criteria with amplitude and peak-to-peak spacing.
Embodiments of the present invention provide a method for creating a map of abnormal electrical activity in the heart of a living patient. In this method, electrical signal data is obtained from each position of the heart, the signal data is automatically analyzed to identify complex subdivision electrograms in the signal data, and the complex subdivision electrogram space in the heart is determined. Displays information obtained from signal data suggesting a spatial distribution.
According to certain aspects of the method, the automatic analysis of the signal data identifies a voltage peak having an amplitude within a predetermined voltage range and occurs within a predetermined time range. Identifying the peak-to-peak spacing between voltage peaks.
In another aspect of the method, the electrical signal is contacted with the surface of the heart using a catheter having a position sensor and electrodes disposed distally, and the electrical signal is measured through the electrodes at each location. , By determining position information from a position sensor of at least one point on the surface of the heart. This electrical signal can be measured using monopolar or bipolar electrodes. The cardiac surface can be an endocardial surface or an epicardial surface. Each location can be in the atrium or ventricle of the heart.
In another aspect of the method, the electrical signal data includes a plurality of electrodes arranged on the outer surface of the patient, the electrical signals are detected from the heart using the plurality of electrodes, and the values of the electrical signals are set in a preset impedance matrix. Obtained from each position of the heart by applying to and identifying each position.
According to certain aspects of the method, displaying the information includes creating a functional map of the heart. This functional map can be encoded according to the average period of the complex subdivision electrogram, the shortest complex period of the complex subdivision electrogram, or according to the number of complex subdivision electrograms detected at each location.
Another aspect of the method includes ablating cardiac tissue associated with the complex subdivision electrogram.
Computer software products and apparatus are also provided for the implementation of this method.
For a better understanding of the present invention, reference is made to the following detailed description, by way of example only, with reference to the accompanying drawings. In each drawing, the same reference numerals are assigned to the same components.
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced without such specific details. In other instances, details of well-known circuits, control logic, and computer program instructions for conventional algorithms and processes have not been shown in detail in order not to unnecessarily obscure the present invention.
Software programming code embodying aspects of the invention is typically maintained in a permanent storage device, such as a computer readable medium. In a client-server environment, such software programming code can be stored on the client or server. The software programming code can be embodied on any known medium for use with a data processing system. Examples of this include, but are not limited to, computer instructions embodied in a disk drive, magnetic tape, compact disk (CD), digital video disk (DVD), and transmission medium that includes or does not include a carrier wave on which a signal is modulated. There may be mentioned magnetic storage devices such as signals or optical storage devices. For example, the transmission medium can be a communication network such as the Internet. In addition, the present invention can be embodied in computer software, but the functions necessary to implement the present invention are alternatively hardware components such as application specific integrated circuits, other hardware, or hardware. Some or all of the wear components and software can be implemented using some combination.
System Configuration Turning to the accompanying drawings, refer first to FIG. FIG. 1 is a pictorial diagram of a system 10 for detecting areas of abnormal electrical activity in a heart 12 of a living patient 21 and performing an ablation procedure in accordance with a disclosed embodiment of the present invention. The system includes a probe, which is typically a catheter 14. An operator 16, usually a physician, inserts the catheter 14 percutaneously and sends it through the patient's vasculature into the ventricle or heart vasculature. The operator 16 brings the catheter distal tip 18 into contact with the heart wall at the target site to be evaluated. Next, U.S. Pat. Nos. 6,226,542 and 6,301,496, as described above, and U.S. Patents assigned to the assignee of the present invention, the entire disclosure of which is incorporated herein by reference. An electrical activity map is created according to the method disclosed in US Pat. No. 6,892,091.
The area determined to be abnormal by the evaluation of the electrical activity map can be ablated by applying thermal energy. Specifically, for example, a radio frequency current is passed through the catheter wire to one or more electrodes of its distal tip 18 to supply this radio frequency energy to the myocardium. Energy is absorbed into the tissue and the tissue is heated to a point where it permanently loses electrical excitement (usually about 50 ° C.). If successful, this procedure creates a non-conductive trauma in the heart tissue. This trauma blocks the abnormal electrical pathway that causes the arrhythmia. Alternatively, other known methods of applying ablation energy, such as ultrasonic energy, may be used, as disclosed in U.S. Patent Application Publication No. 2004/0102769, the disclosure of which is incorporated herein by reference. it can. Although the principles of the present invention are disclosed for atrial complex fractionated electrograms, mapping in all ventricular, epicardial and endocardial surgeries and sinus rhythms and various Applicable when cardiac arrhythmia is present.
The catheter 14 typically includes a handle 20 with appropriate controls so that an operator 16 can maneuver, position and orient the distal end of the catheter as desired for ablation. To assist operator 16, the distal portion of catheter 14 includes a position sensor (not shown) that provides a signal to positioning processor 22 located at console 24. Catheter 14 may be obtained with the necessary modifications to the ablation catheter disclosed in US Pat. No. 6,669,692 assigned to the assignee of the present invention, the disclosure of which is incorporated herein by reference. Can do. The console 24 typically includes an ablation energy generator 43.
The positioning processor 22 is an element of the positioning subsystem 26 that measures the position and orientation coordinates of the catheter 14. Throughout this application, the term “location” refers to the spatial coordinates of the catheter and the term “orientation” refers to the angular coordinates of the catheter. The term “position” refers to the full positional information of the catheter, including both position and orientation coordinates.
In one embodiment, positioning subsystem 26 includes a magnetic position tracking system that determines the position and orientation of catheter 14. The positioning subsystem 26 generates a magnetic field in a predetermined working volume in the vicinity thereof and detects this magnetic field with a catheter. The positioning subsystem 26 typically includes a set of external radiators such as a coil 28 that generates a field at a known fixed position external to the patient. Coil 28 generates a field, usually an electromagnetic field, in the vicinity of heart 12.
In an alternative embodiment, the emitter of the catheter 14, such as a coil, generates an electromagnetic field that is received by a sensor (not shown) outside the patient's body.
Certain position tracking systems that can be used for this purpose have been assigned to the assignee of the present invention, for example, US Pat. No. 6,690,963, referenced above, the entire disclosure of which is incorporated herein by reference. U.S. Patent Nos. 6,618,612 and 6,332,089, and U.S. Patent Application Publication Nos. 2004/0147920 and 2004/0068178. Although the positioning subsystem 26 shown in FIG. 1 utilizes a magnetic field, the method described below is useful for any other suitable positioning sub-system such as a system based on electromagnetic, acoustic, or ultrasonic measurements. Can be implemented using the system.
Refer now to FIG. FIG. 2 is a diagram of an embodiment of a catheter 14 for use in the system 10 (FIG. 1). Catheter 14 is a mapping / therapy delivery catheter for insertion into the human body and delivery into the heart chamber of heart 12 (FIG. 1). The illustrated catheter is merely exemplary, and various other types of catheters can be used as the catheter 14. Catheter 14 includes a body 30. An electrode 32 is provided on the distal portion 34 of the catheter to measure the electrical properties of the heart tissue. The electrode 32 is also useful for sending electrical signals to the heart, for example, for diagnostic purposes such as for electrical mapping and / or therapeutic purposes such as for ablation of defective heart tissue. The distal portion 34 further includes an array 36 of non-contact electrodes 38 for measuring long field electromagnetic signals in the ventricle. The array 36 is a linear array in which non-contact electrodes 38 are linearly arranged along the longitudinal axis of the distal portion 34. The distal portion 34 further includes at least one position sensor 40 that generates a signal used to determine the position and orientation of the distal tip 18 within the body. The position sensor 40 is preferably proximate to the distal tip 18. There is a fixed placement and orientation relationship of the position sensor 40, the distal tip 18, and the electrode 32.
The position sensor 40 transmits position related electrical signals to the console 24 via a cable 42 passing through the catheter 14 in response to the field generated by the positioning subsystem 26 (FIG. 1). Alternatively, the position sensor 40 in the catheter 14 may provide a wireless link as disclosed in U.S. Patent Application Publication Nos. 2003/0120150 and 2005/0099290, the disclosures of which are incorporated herein by reference. Signals can also be sent to the console 24 via The positioning processor 22 then calculates the position and orientation of the distal portion 34 of the catheter 14 based on the signal transmitted by the position sensor 40. The positioning processor 22 typically receives, amplifies, filters, digitizes, and performs other processing signals from the catheter 14. The positioning processor 22 provides a signal output to a display 44 that visually displays the position of the distal portion 34 and / or the distal tip 18 of the catheter 14 relative to the site selected for ablation.
The handle 20 of the catheter 14 includes a control 46 to steer or deflect the distal portion 34 or change the orientation of the distal portion 34 as desired.
Cable 42 includes a receptacle 48 connected to handle 20. The receptacle 48 is preferably configured to receive a specific model catheter and preferably includes identification of the specific model that is user-friendly. One advantage of using cable 42 is that various models and types of catheters, such as catheters with different handle constructions, can be connected to the same console 24 (FIG. 1). Another advantage of having a separate cable 42 is the fact that the cable 42 can be reused without sterilization because it does not contact the patient. Cable 42 further includes one or more isolation transformers (not shown) that electrically isolate catheter 14 from console 24. An isolation transformer can be included in the receptacle 48. Alternatively, an isolation transformer can be included in the electronics of the console 24 system.
Refer again to FIG. System 10 can be implemented as the above-described CARTO XP EP Navigation and Ablation System with appropriate modifications to perform the procedures disclosed herein.
Using the electrical mapping system 10 (FIG. 1), an electrical activity map of the ventricle of the heart 12 can be generated by the method disclosed in the above-mentioned US Pat. No. 6,892,091. An overview of one such method modified according to aspects of the present invention will facilitate an understanding of the present invention. Refer now to FIG. FIG. 3 shows the distal end of the catheter 14 in contact with the endocardial surface 50 of the right atrium 52 of the heart 12 according to a disclosed embodiment of the present invention. Electrode 32 remains in contact with endocardial surface 50 at current contact point 54 during at least one full cardiac cycle. During this time, position information is continuously measured by position sensor 40 (FIG. 2) and electrical information, preferably voltage (as a function of time), is provided for each non-contact electrode of electrode 32 and array 36 (FIG. 2). 38.
Once the electrical and positional information described above is collected at contact point 54, electrode 32 is brought into contact with another contact point, such as another contact point 56 on the endocardial surface of right atrium 52. A point 58 indicated by an asterisk represents the position of the non-contact electrode 38 when the electrode 32 is in contact with the contact point 54.
The electrode 32 advances over a plurality of contact points on the endocardial surface of the ventricle. The position and electrical information is obtained while the contact electrode is in contact with each contact point. Usually, the step of obtaining information by making contact is performed at 5 to 15 such contact points. Due to the presence of multiple non-contact electrodes 38, the total number of points used for ventricular data acquisition would be 160 or more. The location and electrical information obtained from electrode 32 and non-contact electrode 38 at each acquisition step is the basis for creating an electrical map of the ventricle.
The position of the contact electrode at each contact point can be used to define a geometric map of the ventricle. In practice, although not in contact with the heart surface, the entire position of the non-contact electrode defines a “cloud” of space representing the minimum ventricular volume. These non-contact locations can be used to define the shape of the ventricle as an alternative or in conjunction with the location of the electrode 32 at each contact point.
A reference position sensor is preferably used to compensate for cardiac movement due to patient breathing or patient movement during the procedure. One method for obtaining a reference position uses a reference catheter (not shown) that includes a reference position sensor elsewhere in the heart. Alternatively, the reference position sensor can be included in a pad that can be attached to the exterior of the patient, eg, the patient's back. In either case, the position determined by the sensor housed in the mapping catheter can be corrected for patient movement using a reference sensor.
A suitable method for creating an electrical map of the heart from the acquired location and electrical information is disclosed in the aforementioned US Pat. No. 6,226,542. Briefly, an initial, generally arbitrary, closed three-dimensional surface (also referred to herein as a curve for simplicity) is defined in a reconstruction space in the volume of extracted points. . This closed curve is roughly adjusted to a shape similar to the reconstruction of the extracted points. The flexible alignment step is then preferably repeated one or more times so that this closed curve closely resembles the shape of the actual volume being reconstructed. This three-dimensional curved surface can be displayed on a video display or other screen for viewing by a physician or other user of the map.
The initial closed curved surface preferably includes substantially all extraction points or is substantially inside all extraction points. However, note that all curves near the extracted point are appropriate. Preferably, the closed 3D curved surface comprises an ellipse or any other simple closed curve. Alternatively, an unclosed curve can be used, for example if it is desired to reconstruct one wall rather than the entire volume.
A grid of the desired density is defined on the curve. A vector is defined for each point on the grid. This vector depends on the displacement between one or more measured positions on the heart surface and one or more grid points. Since the surface can be adjusted by moving each grid point according to the respective vector, the reconstructed surface can be deformed to resemble the actual structure of the ventricle. The grid preferably divides the curved surface into a quadrilateral or any other polygon so as to equally define each point in the curve. It is preferable that the density of the grid is sufficient and that there are generally more grid points than extracted points at any periphery. More preferably, the density of the grid can be adjusted by a desired concession between the accuracy and speed of the reconstruction.
Identifying CFAEs CFAEs are nominally defined as regions that exhibit one of the following characteristics: In practice, the user or operator can change these characteristics based on the user's experience and judgment for a particular patient. (1) A segment of the atrium with a baseline perturbation due to a continuous bias of a long complex over a recording period of 10 seconds and / or a subdivision electrogram made of two or more biases . Or (2) a region of the atrium whose electrogram has a very short average cycle (eg, 120 milliseconds) for a 10 second recording period. This recording period is not so important, and recording intervals of other lengths can be used.
In an aspect of this embodiment, the number of intervals between complexes is represented. However, this is not limiting and other types of information obtained from data manipulation may also constitute criteria representing the number and characteristics of the complex.
Refer now to FIG. FIG. 4 is an exemplary electrogram illustrating a CFAE that can be automatically identified according to the disclosed embodiments of the present invention. These electrograms are taken from the above-mentioned article by Nademanee et al. One type of CFAE is illustrated by electrogram 60. Electrogram 60 shows a continuous long complex for the posterior septal area. Reference traces from lead II and V2 are shown by graphs 62 and 64, respectively. Another type of CFAE is shown by electrogram 66 obtained on the roof of the left atrium. The length of the cycle is much shorter than the rest of the left atrium. A reference trace from guide line aVF is shown by graph 68.
In order to specify the CFAE, a subdivision complex period map creation tool was created by modifying the system software of the above-mentioned CARTO XP EP Navigation / Ablation System. Although this software will be described using this particular system, the present invention is not limited to the Kurt XP EP navigation / ablation system and those skilled in the art will apply to various other electrical mapping systems. be able to.
Complex Period Detection Refer now to FIG. FIG. 5 is a block diagram illustrating a subsystem 86 that includes aspects of system 10 (FIG. 1) in accordance with the disclosed embodiments of the present invention. Subsystem 86 processes signal 70 from catheter 14 indicating cardiac electrical activity. In signal preparation block 72, the signal is subjected to conventional signal processing and conditioning, such as amplification and filtering. Analog / digital conversion is performed at block 74. The prepared signal is then analyzed by a processor 76 that can be implemented as a general purpose computer. Typically, the functions represented by blocks 72, 74 and processor 76 are included in console 24 (FIG. 1).
The processor 76 includes a memory 78 that contains objects that match the functional blocks shown therein. Alternatively, the objects shown in memory 78 can be implemented as dedicated hardware modules or conventional types of firmware.
To detect CFAE, the signal 70 is analyzed for the presence of peaks that meet predetermined criteria of magnitude and frequency. In essence, signal data is automatically analyzed to identify voltage peaks with amplitudes within a predetermined voltage range, and peaks and peaks between specified voltage peaks that occur within a predetermined time range. Is specified. This is done using a peak detection module 80, a peak quantification module 82, and a frequency analyzer 84 that are well known in the art and will not be described in detail. In fact, all functions shown in the memory 78 are included in the above-described CARTO XP EP Navigation and Ablation System and can be called by the system and application software.
Operation Based on default or user-configured complex definitions, subsystem 86 detects qualifying peaks that meet a predetermined voltage criterion, identifies the number of intervals between adjacent qualifying peaks, Identify the interval between intervals. Each pair of eligible peaks separated by a range of predetermined intervals establishes two complexes . Thus, the system identifies complexes within the amplitude and duration values. As can be seen from the following description, a functional map representing the spatial distribution and characteristics of the complex is created. This functional map can be displayed and compared with a map obtained from another study on the same patient or another patient. This allows the user to compare data, diagnostic plans, and treatment plans. Several types of functional maps can be created by subsystem 86.
Refer now to FIG. FIG. 6 is a functional map of the left atrium of the heart showing the average cycle length between identified CFAEs according to a disclosed embodiment of the present invention. The color scale bar indicates the maximum duration and the minimum duration of the detected time interval. A fill threshold determined by the user is established for the display of the color of the region by each mapping point. This prevents a wide area that does not have actual data from being colored. In FIG. 6, the region 88 is not colored because it does not meet the required threshold. Region 90 corresponds to a region where the average interval between complexes is about 61 milliseconds. In the relatively small area 92, the average interval is significantly longer, approximately 116 milliseconds. A circle 94 is a confidence level tag. By default, three types of color-coded confidence level tags are displayed that match the measurements of the seven intervals, four intervals, and two intervals between exams. Circle 94 corresponds to an intermediate confidence level of four measured intervals between CFAEs. The mapping points 96 are shown as small points distributed on the map.
Refer now to FIG. FIG. 7 is a functional map of the left atrium of the heart showing the shortest interval between CFAEs for which the color scale has been identified for each acquired point, in accordance with the disclosed embodiment of the present invention. A number of mapping points 96 are shown. Alternatively or in addition, a confidence level tag or textual labels (not shown) can indicate the confidence level in the map. Regions 98 and 100 correspond to long intervals between CFAEs, and regions 102 and 104 correspond to short intervals. Circles 106 and 108 represent local, color-coded confidence levels.
Refer now to FIG. FIG. 8 is a left atrial interval confidence map shown in FIG. 7 according to a disclosed embodiment of the present invention. The color scale shows the number of repeated CFAEs detected, i.e. the number of eligible intervals between adjacent complexes for each acquired point. Region 110 has a relatively large number of repeated complexes and is color coded according to the number of complexes. Region 112 shows CFAE repeated very few times. Circles 106 and 108 coincide with circles 106 and 108 in FIG.
Thus, for the shortest interval display of FIG. 7, the confidence level of the interval data is immediately determined with reference to the color coding of circles 106 and 108, which is an essential citation of the more detailed confidence level map of FIG. can do.
In all the functional maps described above, the default confidence level coding can be changed by the user, and tags can optionally be added to meet the confidence level determined by the user.
Please refer to FIG. 5 again. The processor 76 performs a detection algorithm for each mapped point or pair of mapped points. Refer now to FIG. FIG. 9 is a flowchart illustrating a method of CFAE detection according to a disclosed embodiment of the present invention. Assume that the patient study is ongoing or completed and that voltage tracing records have been stored. Alternatively or in addition, an anatomical map is created and superimposed on the CFAE functional map or displayed simultaneously. In the first step 114, parameters are set. Table 1 shows appropriate default parameters for peak detection and peak duration. All of these parameters can be changed by the user.
Next, at step 116, a voltage trace record is selected from the available measurements.
Next, at step 118, the voltage trace recording is converted to digital form using conventional signal processing and conditioning techniques. The digitized record was scanned to detect all peaks where the voltage was between the minimum and maximum thresholds. In addition, if the “beyond peak” mode is set, the peak for which the voltage excursion exceeds the maximum threshold or falls below the minimum threshold is included in the algorithm calculation. Therefore, it is wrong to ignore high voltage trace recording.
Next, in step 120, the time interval between the peaks identified in step 118 is measured. The number of peak-to-peak intervals that fall between the minimum and maximum periods is recorded as the identified complex . The number of peaks, voltage values, and peak-to-peak spacing data are typically stored in an array for convenient recall during mapping. The peaks can be identified and characterized on the annotation display.
Refer now to FIG. FIG. 10 illustrates a trace 122 annotated with peaks and peak-to-peak intervals identified during the implementation of steps 118 and 120 (FIG. 9), according to disclosed embodiments of the invention. It is a screen display of the annotation viewer of the subsystem 86 (FIG. 5). The range between the minimum voltage threshold and the maximum voltage threshold is surrounded by parallel lines 124 and 126, respectively. Five representative qualified peaks having voltage amplitudes within the voltage range defined by parallel lines 124 and 126 are indicated by vertical arrows 128, 130, 132, 134, and 135. If the two peaks 136 and 138 exceed the range defined by the minimum and maximum voltage thresholds, but an optional “beyond peak” mode is possible, they are included in the calculation. For example, in trace 122, two CFAEs separated by a short cycle are identified by arrows 128 and 130.
Please refer to FIG. 9 again. At step 140, the average interval, the shortest interval, and the spatial confidence level distribution are calculated and recorded.
Next, proceed to decision step 142 to determine if there are any traces to be evaluated. If the determination at decision step 142 is affirmative, then return to step 116.
If the determination at decision step 142 is negative, the process proceeds to step 144. Using the data calculated in steps 118 and 120, a CFAE map whose examples are shown in FIGS. Such a functional map can be created using known methods such as taught in, for example, the aforementioned US Pat. Nos. 6,226,542 and 6,301,496. The user can adjust the default parameters (Table 1) used to color the interval confidence level map. The user can set a flag that determines whether to display or hide the confidence level tag. As described above, in one embodiment, such a tag can be represented as a colored circle, where the color of the circle indicates the confidence level of the provisional colored region, and the region A tag appears at the top of.
Refer now to FIG. FIG. 11 is a screen display of a point list of data that can be displayed simultaneously with any of the CFAE maps described above, in accordance with the disclosed embodiment of the present invention. For each mapped data point, the shortest complex interval (SCI) between two consecutive CFAEs is shown in column 146. The point spacing confidence level (ICL) is shown in column 148. If there are two or more adjacent complexes in the signal, column 148 displays the number of CFAE intervals. Column 150 indicates the type of confidence level tag (CLT) used for the points. Although not shown in FIG. 11, if the average complex interval map is displayed simultaneously, the point list also includes an indication of the average complex interval for all complex intervals in the signal.
Please refer to FIG. 9 again. In a final step 152, the user can bring up a CFAE map created for display in various combinations, creating a window where other studies are displayed for comparison with the current study. be able to. The heart tissue associated with the complex subdivision electrogram can be ablated conventionally.
In this embodiment, the first criteria described in the “CFAE Identification” portion of the specification is applied using the system 10 (FIG. 1). This is done by recording for a long period of time, for example 50 seconds, and detecting two complexes within an interval of 10 seconds at some point. Alternatively, the average baseline can be recorded and the data scanned for long deviations to detect long perturbations of the baseline over 10 seconds.
Reference is now made to FIG. FIG. 12 is an illustration of a system 154 configured and operating in accordance with an alternative embodiment of the present invention. System 154 is similar to system 10 (FIG. 1). However, processor 22 is disclosed in US patent application Ser. No. 11 / 030,934, filed Jan. 7, 2005, assigned to the assignee of the present invention, the disclosure of which is incorporated herein by reference. Including an electrical circuit for impedance detection. However, patient 21 typically wears a torso vest 156 having a plurality of electrodes 158 of about 125 to 250. Electrodes 158 are disposed in the torso vest 156 for measuring the forward, backward, and lateral potentials of the patient 21 torso. The electrode 158 is connected to the processor 22 via a lead wire 160 and a cable 162. The processor 22 is modified to receive and process data from the fuselage vest 156.
The system has been modified to create a multidimensional coefficient matrix based on impedance measurements between a small number of endocardial points and the electrode 158. Next, the reciprocal number of the matrix is determined by US Patent Application Publication No. 2003/0120163 (Yoram Rudy et al.) And US Provisional Patent Application No. 60 / 824,680 filed on September 6, 2006 (name: Estimated as disclosed in “Correlation of Endocardial and Epicardial Maps”). These disclosures are incorporated herein by reference. The inverse matrix may correspond to a map of epicardial or endocardial conductance.
Refer now to FIG. FIG. 13 is a simplified cross-sectional view of a chest 164 showing a torso vest 156 and an electrode 158 disposed around the chest according to a disclosed embodiment of the present invention.
FIG. 13 also shows the right atrium 166 and includes three endocardial points 168, 170, and 172. As described below, impedance is measured between the catheter electrode and electrode 158 located at endocardial points 168, 170, and 172. For certain applications, impedance can also be measured between an electrode (not shown in FIG. 13) placed in the epicardium and the electrode 158.
Using this matrix and the other features described above of processor 22 and positioning subsystem 26 to determine the location of points 168, 170, and 172, the conductance of the different points in the cardiac cycle is measured, and the CFAE criterion is defined as point 168, Apply as described above for identification of CFAE at 170 and 172. Such a point can be identified non-invasively in the same session or in a later session using a preset matrix and is a candidate location for ablation in a later session.
Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described. Rather, the scope of the present invention encompasses both the various feature combinations and subcombinations described herein, as well as variations of the features described above, which are not in the prior art, and would occur to those skilled in the art upon reading the above description. Includes variations.
(1) In a method for creating a map of abnormal electrical activity in the heart of a living patient,
Obtaining electrical signal data from each location of the heart;
Automatically analyzing the signal data to identify a complex subdivision electrogram in the signal data;
Displaying information obtained from the signal data suggesting a spatial distribution of the complex subdivision electrogram in the heart;
(2) In the method according to the embodiment (1),
Automatically analyzing the signal data comprises:
Identifying a voltage peak having an amplitude within a predetermined voltage range;
Identifying a peak-to-peak interval between the identified voltage peaks occurring within a predetermined time range;
(3) In the method according to the embodiment (1),
Obtaining the electrical signal data comprises:
Contacting the surface of the heart with a catheter, the catheter having a position sensor and an electrode disposed distally of the catheter;
Measuring electrical signals at the respective positions via the electrodes and obtaining position information from the position sensor at at least one point on the surface;
(4) In the method according to the embodiment (3),
The method of measuring the electrical signal is performed using a monopolar electrode.
(5) In the method according to embodiment (3),
The method of measuring the electrical signal is performed using a bipolar electrode.
(6) In the method according to embodiment (3),
The method wherein the surface is an endocardial surface.
(7) In the method according to the embodiment (1),
The method wherein the respective locations are locations in the heart atrium.
(8) In the method according to the embodiment (1),
The method wherein each location is a location in a ventricle of the heart.
(9) In the method according to the embodiment (1),
The method wherein at least a portion of the respective location is on the endocardial surface of the heart.
(10) In the method according to the embodiment (1),
The method wherein at least a portion of the respective location is on the epicardial surface of the heart.
(11) In the method according to the embodiment (1),
Obtaining electrical signal data from each location of the heart,
Placing a plurality of electrodes on the outer surface of the patient;
Detecting an electrical signal from the heart using the plurality of electrodes;
Applying the electrical signal to a preset impedance matrix to identify the respective positions;
(12) In the method according to embodiment (1),
The method of displaying the information includes creating a functional map of the heart encoded according to an average duration of the complex subdivision electrogram.
(13) In the method according to embodiment (1),
The method of displaying the information comprises creating a functional map of the heart encoded according to a shortest complex period of the complex subdivision electrogram.
(14) In the method according to the embodiment (1),
Displaying the information comprises creating a functional map of the heart that is encoded according to the number of complex subdivision electrograms detected at the respective locations.
(15) In the method according to embodiment (1),
Ablating cardiac tissue associated with the complex subdivision electrogram;
(16) A computer software product for creating a map of electrical activity in the heart of a living patient, comprising a tangible computer readable medium having stored computer program instructions,
When the computer program instructions are read by a computer, the computer
Storing electrical signal data from each location of the heart;
Automatically analyzing the signal data to identify complex fragmentation electrograms in the signal data;
Outputting information indicating a spatial distribution of the complex subdivision electrogram in the heart to a display;
(17) In the computer software product according to the embodiment (16),
The computer identifies a voltage peak having an amplitude within a predetermined voltage range, and a peak-to-peak interval between the specified voltage peaks that occur within a predetermined time range. A computer software product that is further instructed to automatically analyze the signal data by specifying peak intervals.
(18) In the computer software product according to the embodiment (16),
A computer software product, wherein the computer is further instructed to create a functional map of the heart encoded according to an average period of the complex subdivision electrogram.
(19) In the computer software product according to the embodiment (16),
A computer software product, wherein the computer is further instructed to create a functional map of the heart encoded according to a shortest complex period of the complex subdivision electrogram.
(20) In the computer software product according to the embodiment (16),
A computer software product, wherein the computer is further instructed to create a functional map of the heart encoded according to the number of complex subdivision electrograms detected at the respective locations.
(21) In an apparatus for creating a map of electrical activity in the heart of a living patient,
A memory for storing electrical signal data from each position of the heart;
The heart accessing the memory and automatically analyzing the signal data, identifying a complex subdivision electrogram in the signal data, and suggesting a spatial distribution of the complex subdivision electrogram in the heart A processor that operates to create a functional map of
A display linked to the processor for displaying the functional map;
(22) In the device according to embodiment (21),
The processor identifies voltage peaks having an amplitude within a predetermined voltage range and identifies a peak-to-peak interval between the identified voltage peaks that occurs within a predetermined time range. By means of an apparatus for automatically analyzing said signal data.
(23) In the device according to the embodiment (21),
The apparatus, wherein the functional map is encoded by the processor according to an average period of the complex subdivision electrogram.
(24) In the device according to embodiment (21),
The apparatus, wherein the functional map is encoded by the processor according to a shortest complex period of the complex subdivision electrogram.
(25) In the device according to embodiment (21),
The apparatus wherein the functional map of the heart is encoded by the processor according to the number of complex subdivision electrograms detected at the respective locations.
1 is a pictorial diagram of a system for detecting an area of abnormal electrical activity and performing an ablation procedure on a living patient's heart according to a disclosed embodiment of the present invention. FIG. FIG. 2 is a diagram of an embodiment of a catheter for use in the system shown in FIG. FIG. 4 is a diagram illustrating the distal end of a catheter in contact with the endocardial surface of the right atrium of the heart, in accordance with a disclosed embodiment of the present invention. FIG. 6 is a plurality of exemplary electrograms illustrating CFAEs that can be automatically identified according to disclosed embodiments of the present invention. FIG. 2 is a block diagram illustrating a subsystem of the system shown in FIG. 1 according to a disclosed embodiment of the invention. In accordance with the disclosed embodiment of the present invention, the color scale is a functional map of the left atrium showing the average cycle length between identified CFAEs. FIG. 5 is a left atrial functional map showing the shortest interval between CFAEs for which a color scale has been identified for each acquired point, according to disclosed embodiments of the present invention. 3 is a left atrial interval confidence map in accordance with a disclosed embodiment of the present invention. 6 is a flowchart illustrating a method of CFAE detection according to a disclosed embodiment of the invention. In a screen display illustrating a trace, annotated with the peaks identified during the performance of the method shown in FIG. 9 and the peak-to-peak spacing, in accordance with the disclosed embodiment of the present invention. is there. 4 is a screen display of a data point list obtained in accordance with a disclosed embodiment of the present invention. FIG. 2 is an illustration of a system for detecting an area of abnormal electrical activity and performing an ablation procedure on a living patient's heart according to an alternative embodiment of the present invention. FIG. 6 is a simplified cross-sectional view of a chest showing a torso vest and electrodes according to an alternative embodiment of the present invention.
In a computer program for creating a map of electrical activity in a living patient's heart, including instructions, said instructions being read by a computer,
Automatically analyzing the electrical signal data to identify complex fractionated electrograms in the electrical signal data,
Outputting a functional map showing the spatial distribution of the complex subdivision electrogram in the heart to a display;
The computer identifies the voltage peaks having amplitudes within the voltage range set in advance, for the previous SL voltage peaks identified, to identify the respective distance between the peak and the peak between two consecutive voltage peaks of the distance between the identified peak and peak, by identifying what falls within the time range interval is predetermined, and further instructions to automatically analyze the electrical signal data,
The computer, to indicate the region having a group made by grouping the number of pre-Symbol interval to be within a time range interval is predetermined to create the functional map of the heart is further instruction,
A computer readable medium storing the computer program according to claim 1.
In a device for mapping electrical activity in the heart of a living patient,
Accessing the memory and automatically analyze the electrical signal data, thereby, to identify complex fractionated electrograms in the electrical signal data, and spatial distribution of the complex fractionated electrograms in said heart A processor operable to create a functional map of the heart indicating
Wherein the processor is configured to identify voltage peaks having amplitudes within the voltage range set in advance, for the previous SL voltage peaks identified, to identify the respective distance between the peak and the peak between two consecutive voltage peaks , By specifying the interval between the specified peak and the peak, the interval is within a predetermined time range, and operates to automatically analyze the electrical signal data,
The function map, by grouping the number of pre-Symbol interval to be within a time range interval is predetermined, shows the area having a fabricated group,
JP2007003735A 2006-01-12 2007-01-11 Computer program, computer readable medium and apparatus for generating complex fragmented atrial electrograms Active JP5819035B2 (en)
US60/758,317 2006-01-12
US11/620,370 2007-01-05
JP2007185516A JP2007185516A (en) 2007-07-26
JP2007185516A5 JP2007185516A5 (en) 2010-01-28
JP5819035B2 true JP5819035B2 (en) 2015-11-18
JP2007003735A Active JP5819035B2 (en) 2006-01-12 2007-01-11 Computer program, computer readable medium and apparatus for generating complex fragmented atrial electrograms
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